Speculum, Vaginal, Metal

Who Makes This Device Type in China?

8 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Jiangsu and Fujian, and 2 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Jiangsu WLD Medical Co., Ltd. Jiangsu, contract manufacturer
Shanghai Dynamic Medical Supplies Co., Ltd. Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Wilpower Industrial Co., Ltd. Shanghai
Xinhua Surgical Instrument Co., Ltd. Shandong
Xiamen Zhiyuan Medical Technology Co., Ltd. Fujian, contract manufacturer

How Is HDF Classified?

Speculum, Vaginal, Metal is FDA product code HDF, Class 1, 21 CFR 884.4520.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (1) and Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Speculum, Vaginal, Metal

Lletz Pederson Vu-More Speculum Large

Lletz Pederson Vu-More Speculum Large 4 7/8" (124mm)

Speculum, Vaginal, Metal

Graves Vu-More Titanium Medium

Graves Vu-More Titanium Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Pederson Medium – Left Side Open

Pederson Medium - Left Side Open 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Medgyn MVP-100 Vacuum Pump

MVP-100 Vacuum Pump

Speculum, Vaginal, Metal

Symmetry Hartmann

Symmetry® Speculum, Hartmann, Chrome Plated, Round, (4/st)

Speculum, Vaginal, Metal

Vaginal Retractor

Vaginal Lateral Wall Retractor

Speculum, Vaginal, Metal

Repaired Products

Catalogue number Repaired Products, listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Cusco Large W/side Screw

Cusco Large w/Side Screw 1 3/8" x 4 1/2" (35mm x 114mm)

Speculum, Vaginal, Metal

Lletz Pederson Vu-More Speculum Extra Large

Lletz Pederson Vu-More Speculum Extra Large 5 7/8" (149mm)

Speculum, Vaginal, Metal

Lletz Graves Vu-Max Speculum Medium

Lletz Graves Vu-Max Speculum Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Graves Vu-More X Long

Graves Vu-More X Long 6 1/3" (161mm)

Speculum, Vaginal, Metal

Symmetry O’Sullivan

Symmetry® Speculum, O'Sullivan O'Connor Vaginal

Speculum, Vaginal, Metal

Weisman Graves Speculum Small – Right Side Open

Weisman Graves Speculum Small - Right Side Open 3/8" x 3" (10mm x 76mm)

Speculum, Vaginal, Metal

Auvard 3.0lbs, 75° Angle, Blade

Auvard 3.0lbs, 75° angle, Blade 1 1/2" x 3 1/4" (38mm x 83mm)

Speculum, Vaginal, Metal

Pederson XNarrow

Pederson XNarrow - Right Side Open 5/8" x 4" (17mm x 102mm)

Speculum, Vaginal, Metal

Cusco Specula Metal Large

Catalogue number CMM200L, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Graves Speculum X Large

Graves Speculum X Large 1 1/2" x 6 1/2" (38mm x 165mm)

Speculum, Vaginal, Metal

Pederson Vu-Max Titanium Medium

Pederson Vu-Max Titanium Medium 4 1/2" (145mm)

Speculum, Vaginal, Metal

Lletz Graves Vu-More Speculum Large

Lletz Graves Vu-More Speculum Large 4 7/8" (124mm)

Speculum, Vaginal, Metal

Lletz Graves Speculum Small, Closed Tube

Lletz Graves Speculum Small, Closed Tube 3/4 inch x 3inch (19mm x 76mm)

Speculum, Vaginal, Metal

Auvard 2.0lbs, 75° Angle, Blade

Auvard 2.0lbs, 75° angle, Blade 11/2" x3 1/4" (38mm x 83mm)

Speculum, Vaginal, Metal

Leep- Snowman Graves Speculum

LEEP- Snowman Graves Speculum- Coated

Speculum, Vaginal, Metal

Cusco Specula Insulated With Smoke Tube Large

Catalogue number CSI200L, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Pederson Speculum Medium

Catalogue number SP104, listed by Biopsy Fine Cut Instruments, Pakistan, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Leep TruView Lateral Wall Retractor

LEEP TruView Lateral Wall retractor - Coated

Speculum, Vaginal, Metal

Rotating Shaft – Tischler Tip – Down

Catalogue number Rotating Shaft - Tischler Tip - Down, listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Symmetry Kogan

Symmetry® Dilator, Kogan Endocervical, w/Gauge And Screw, 9 3/4 in

Speculum, Vaginal, Metal

Leep Auvard Speculum

LEEP Auvard Speculum - Coated- Medium

Speculum, Vaginal, Metal

Kogan 2-4mm W/screw

Catalogue number Kogan 2-4mm w/screw, listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Weisman Graves Medium

Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Lletz Graves Vu-More Speculum Medium Closed Tube

Lletz Graves Vu-More Speculum Medium Closed Tube 1 1/4" x 4" (32mm x 102mm)

Speculum, Vaginal, Metal

Lletz Foerster Forceps – Straight

Lletz Foerster Forceps - Straight 9 1/2" (241mm)

Speculum, Vaginal, Metal

Pederson Medium – Right Side Open

Pederson Medium - Right Side Open 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Lletz Weisman Speculum Right Side Open Large Angled Closed Tube

Open Large Angled Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm)

Speculum, Vaginal, Metal

Graves Wide Angled Medium

Graves Wide Angled Medium 45° 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Lletz Graves Speculum Extra Large, Closed Tube

Lletz Graves Speculum Extra Large, Closed Tube 1 1/2" x 61/2" (38mm x 165mm)

Speculum, Vaginal, Metal

Lletz Pederson Speculum Small, Closed Tube

Lletz Pederson Speculum Small, Closed Tube 1/2" x 3" (13mm x 76mm)

Speculum, Vaginal, Metal

Lletz Collins Speculum Large Closed Tube

Lletz Collins Speculum Large Closed Tube 1 5/8" x 4 1/2" (41mm x 114mm)

Speculum, Vaginal, Metal

Lletz Emmet Tenaculum

Lletz Emmet Tenaculum 9” (229mm)

Speculum, Vaginal, Metal

Pederson 45° Large – Right Side Open

Pederson 45° Large - Right Side Open 1" x 4 3/4" (25mm x 121mm)

Speculum, Vaginal, Metal

Lletz Pederson Speculum Medium, Left Side Open, Closed Tube

Closed Tube 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Lletz Tissue Forceps Large

Lletz Tissue Forceps Large 10" (254mm)

Speculum, Vaginal, Metal

Vaginal Speculum – Snowman/ Pederson Blade

Catalogue number 64-117, listed by Coopersurgical, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Rotating Shaft (W/any Tip)

Catalogue number Rotating Shaft (w/any tip), listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Lletz Four Way Lateral Speculum Medium

Lletz Four Way Lateral Speculum Medium 7/8”x4 1/4” (22mm x 108mm)

Speculum, Vaginal, Metal

Lletz Pederson Speculum Medium, Closed Tube

Lletz Pederson Speculum Medium, Closed Tube 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Collins Speculum Medium

Collins Speculum Medium 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

NMcKesson

Vaginal Speculum, Graves, OG Medium 1.38"x3.75"

Speculum, Vaginal, Metal

Graves Vu-More Titanium Large

Graves Vu-More Titanium Large 5" (127mm)

Speculum, Vaginal, Metal

Graves Speculum Medium

Graves Speculum Medium 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Cusco Small W/side Screw

Cusco Small w/Side Screw 1 1/3" x 3 1/2" (32mm x 89mm)

Speculum, Vaginal, Metal

Cusco Specula Insulated With Smoke Tube Small

Catalogue number CSI200S, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Lletz Graves Vu-Max Speculum Closed Tube

Lletz Graves Vu-Max Speculum Closed Tube 1 3/8" x 4 1/2" (35mm x 114mm)

Speculum, Vaginal, Metal

4-Way Lateral Expander Speculum

4-Way Lateral Expander Speculum - Medium 7/8" x 4 1/4" (22mm x 108mm)

Speculum, Vaginal, Metal

Lletz Graves Speculum Extra Long Snowman, Clinton Closed Tube

Clinton Closed Tube 11/2" x 6" (38mm x 152mm)

Speculum, Vaginal, Metal

Lletz Foerster Forceps

Lletz Foerster Forceps - Curved 9 1/2" (241mm)

Speculum, Vaginal, Metal

Lletz Pederson Vu-Max Speculum Medium

Lletz Pederson Vu-Max Speculum Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Lateral Vaginal Wall Retractor – Wide Open

Wall Retractor - Wide Open, 10" (254mm), Blade 1" x 2 1/2" (25mm x 64mm)

Speculum, Vaginal, Metal

Grundman Speculum Small

Grundman Speculum Small 1 1/3" x 3 1/3" (34mm x 85mm)

Speculum, Vaginal, Metal

Lletz Graves Speculum Medium, Closed Tube

Lletz Graves Speculum Medium, Closed Tube 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Lletz Tissue Forceps Small

Lletz Tissue Forceps Small 8" (203mm)

Speculum, Vaginal, Metal

Graves VAG Spec LG 4.5

Catalogue number SP003, listed by Biopsy Fine Cut Instruments, Pakistan, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Graves Vu-More X Long 7″ (178mm)

Catalogue number Graves Vu-More XLong 7" (178mm), listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Pederson Large – Left Side Open

Pederson Large - Left Side Open 1" x 4 3/4" (25mm x 121mm)

Speculum, Vaginal, Metal

Pederson Xlarge – Right Side Open

Pederson Xlarge - Right Side Open 1" x 6 1/2" (25mm x 165mm)

Speculum, Vaginal, Metal

Lletz Pederson Speculum Medium, Right Side Open, Closed Tube

Closed Tube 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Weisman Graves Large

Weisman Graves Large - Left Side Open 1 3/8" x 4 3/4" (35mm x 121mm)

Speculum, Vaginal, Metal

V. Mueller

V. Mueller HUFFMAN INFANT VAGINOSCOPE PARTIALLY CHROME PLATED WORKING LENGTH 2-9/16" (6.5CM)

Speculum, Vaginal, Metal

Pederson Extra Long Snowman Clinton

Pederson Extra Long Snowman Clinton 1" x 6" (25mm x 152mm)

Speculum, Vaginal, Metal

Cusco Large W/center Screw

Cusco Large w/Center Screw 1 3/8" x 4 1/2" (35mm x 114mm)

Speculum, Vaginal, Metal

PRO Advantage

PA Specula Vagninal MD Pederson

Speculum, Vaginal, Metal

Pederson Large

Pederson Large 1" x 4 3/4" (25mm x 121mm)

Speculum, Vaginal, Metal

Leep Vu-Max Graves Speculum

LEEP Vu-Max Graves Speculum - Coated- Medium

Speculum, Vaginal, Metal

Lletz Graves Vu-More Speculum Extra Large

Lletz Graves Vu-More Speculum Extra Large 6 2/3" (169mm)

Speculum, Vaginal, Metal

Cusco Specula Metal Large Long

Catalogue number CMM100LL, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Vaginal Speculum – Graves

Vaginal Speculum - Graves/ Open Sided

Speculum, Vaginal, Metal

Symmetry Berlind-Auvard

Symmetry® Speculum, Berlind-Auvard, 44 mm x 102 mm Blades, 2 1/2 lbs

Speculum, Vaginal, Metal

Pederson Small

Pederson Small 1/2" x 3" (13mm x 76mm)

Speculum, Vaginal, Metal

Coated Graves Specula

Coated Graves Specula Wide Medium

Speculum, Vaginal, Metal

Graves Speculum XSmall

Graves Speculum X Small 3/4" x 2 3/4" (19mm x 70mm)

Speculum, Vaginal, Metal

Lletz Iris Tenaculum Hook

Lletz Iris Tenaculum Hook 9” (229mm)

Speculum, Vaginal, Metal

Graves Wide Angled Large Right Open

Graves Wide Angled Large Right Open 1 3/8" x 4 3/4" (35mm x 121mm)

Speculum, Vaginal, Metal

Graves Vu-Max Titanium Large

Graves Vu-Max Titanium Large 5" (127mm)

Speculum, Vaginal, Metal

Elmed Incorported

Insulated Large Graves VU-More Vaginal Speculum With 1-5/8 Wide Yoke 4-3/4" X 1-1/2"

Speculum, Vaginal, Metal

Lletz Pederson Vu-More Speculum Medium

Lletz Pederson Vu-More Speculum Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Leep Pederson Speculum

LEEP Pederson Speculum - Coated - Medium

Speculum, Vaginal, Metal

Lateral Vaginal Wall Retractor Blue Titanium

Catalogue number Lateral Vaginal Wall Retractor Blue Tita, listed by Medgyn Products, Inc., United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Weisman Graves Medium – Right Side Open

Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Lateral Vaginal Wall Retractor Open

Wall Retractor Open 1/2" (13mm), 10" (254mm), Blade 1" x 2 1/2" (25mm x 64mm)

Speculum, Vaginal, Metal

Graves Vu-More Medium

Graves Vu-More Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Lletz Dressing Forceps Large

Lletz Dressing Forceps Large 10" (254mm)

Speculum, Vaginal, Metal

Pederson XSmall

Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm)

Speculum, Vaginal, Metal

Pederson Vu-More Titanium Medium

Pederson Vu-More Titanium Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Cusco Specula Metal Medium

Catalogue number CMM200M, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Weisman Graves X Large

Weisman Graves X Large - Left Side Open 1 1/2" x 6 1/2" (38mm x 165mm)

Speculum, Vaginal, Metal

Pederson 45° Medium – Right Side Open

Pederson 45° Medium - Right Side Open 7/8" x 4" (22mm x 102mm)

Speculum, Vaginal, Metal

Graves Vu-Max Large

Graves Vu-Max Large 5" (127mm)

Speculum, Vaginal, Metal

Graves Vu-Max Medium

Graves Vu-Max Medium 4 1/2" (114mm)

Speculum, Vaginal, Metal

Cusco Specula Metal Large Extra Long

Catalogue number CMM100LE, listed by DTR Medical Ltd, United Kingdom, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Princeton

Speculum Auvard Vaginal 105MM X 38MM With Fixed Weight 1.4KG (3 LBS)

Speculum, Vaginal, Metal

Symmetry Kristeller

Symmetry® Speculum, Kristeller Vaginal, Concave, Size 2, 1 1/4 in x 4 1/3 in Blades

Speculum, Vaginal, Metal

Symmetry Kelly

Symmetry® Retractor, Kelly, 1 1/2 in x 2 in, Standard Handle, 10 1/4 in

Speculum, Vaginal, Metal

Kmedic

2 catalogue numbers from IPN015575, listed by Teleflex Medical LLC, United States, under Speculum, Vaginal, Metal. 8 manufacturers in China are registered for this product code.

Speculum, Vaginal, Metal

Lletz Collins Speculum Small Closed Tube

Lletz Collins Speculum Small Closed Tube 1 1/4" x 3 3/4" (32mm x 95mm)

Speculum, Vaginal, Metal

Lletz Lateral Vaginal Wall Retractor Open

Lletz Lateral Vaginal Wall Retractor Open 1/2" (13mm), Blade 1" x 2 1/2" (25mm x 64mm)

Speculum, Vaginal, Metal

Weisman Graves Large – Right Side Open

Weisman Graves Large - Right Side Open 1 3/8" x 4 3/4" (35mm x 121mm)

Speculum, Vaginal, Metal

Leep Vu-More Speculum

LEEP Vu-More Speculum - Coated- Medium

Speculum, Vaginal, Metal

Adler Instrument Company

Graves Vaginal Speculum 45 degree open

Speculum, Vaginal, Metal

Lletz Collins Speculum Medium Closed Tube

Lletz Collins Speculum Medium Closed Tube 1 3/8" x 4" (35mm x 102mm)

Speculum, Vaginal, Metal

Lletz Graves Speculum Large, Closed Tube

Lletz Graves Speculum Large, Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm)

Speculum, Vaginal, Metal

Cardinal Health

Sterile Pederson VAG. Speculum

Speculum, Vaginal, Metal

Leep- Snowman Pederson Speculum

LEEP- Snowman Pederson Speculum- Coated

Speculum, Vaginal, Metal

Elmed Incoroporated

Insulated Lateral Wall Vaginal Retractor, Gold Plated Spring Ratchet Handle—closed SHANKS—11” Overall Length, 2 1/2” X 1” Blade Size

Speculum, Vaginal, Metal

Pederson XLarge

Pederson XLarge 1" x 61/2" (25mm x 165mm)

Speculum, Vaginal, Metal

Lletz Pederson Vu-Max Speculum Large

Lletz Pederson Vu-Max Speculum Large 4 7/8" (124mm)

Speculum, Vaginal, Metal

Leep- Mini Vu-More Speculum

LEEP- Mini Vu-More Speculum - Coated

Speculum, Vaginal, Metal

Lletz Graves Vu-More Speculum Large Closed Tube

Lletz Graves Vu-More Speculum Large Closed Tube 1 3/8" x 4 1/2" (35mm x 114mm)

Speculum, Vaginal, Metal

Lletz Single Tooth Tenaculum

Lletz Single Tooth Tenaculum 9 3/4" (248mm)

Speculum, Vaginal, Metal

J&J Instruments

Pederson Vaginal Spec X-Narrow

Speculum, Vaginal, Metal

Lletz Pederson Speculum Large, Closed Tube

Lletz Pederson Speculum Large, Closed Tube 1" x 4 3/4" (25mm x 121mm)

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer