Speculum, Non-Illuminated

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Zhejiang: 3 hold an FDA registration. 1 is a contract manufacturer.

Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer

What Is FDA Product Code FXE?

Speculum, Non-Illuminated is FDA product code FXE, Class 1, 21 CFR 878.1800.

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.

Speculum, Non-Illuminated

Peak Medical

Ear Mounting Speculum with Handle per customer sample. Autoclavable Medical Grade Stainless Steel.

Speculum, Non-Illuminated

Pilling

2 catalogue numbers from IPN017911, listed by Teleflex Medical LLC, United States, under Speculum, Non-Illuminated. 3 manufacturers in China are registered for this product code.

Speculum, Non-Illuminated

Endocervical Speculum

2 catalogue numbers from 2030, listed by Gynex Corporation, United States, under Speculum, Non-Illuminated. 3 manufacturers in China are registered for this product code.

Speculum, Non-Illuminated

Avalign

Chelsea Eaton Anal Speculum

Speculum, Non-Illuminated

Novo Surgical Inc.

hardy bi-valve specula, 13.0 mm x 70.0 mm blades

Speculum, Non-Illuminated

Teales Gorget Speculum

Teales Gorget Speculum Tapered Half-Moon Probe End Angled Flat Handle Titanium

Speculum, Non-Illuminated

Ambler Value Line

Pratt rectal speculum, 8 1/2'', 3 1/2'' long x 1'' diameter, with set screw

Speculum, Non-Illuminated

Symmetry Brinkerhoff

Symmetry® Speculum, Brinkerhoff Rectal, Large, 4 1/2 in

Speculum, Non-Illuminated

Caspar Lumbar Specula

Caspar Lumbar Speculum NON-Reflective Black Annodized Coated

Speculum, Non-Illuminated

Endocervical Speculum, Ratchet Handle

2 catalogue numbers from 2140, listed by Gynex Corporation, United States, under Speculum, Non-Illuminated. 3 manufacturers in China are registered for this product code.

Speculum, Non-Illuminated

Novo Surgical

caspar-type bi-valve specula, 45.0 mm blades

Speculum, Non-Illuminated

Millennium

Ives Fansler Anoscope with plastic obturator

Speculum, Non-Illuminated

HNM Medical

Hardy BI Valve Speculum, 8", Blades 13MMX70MM

Speculum, Non-Illuminated

Princeton

Speculum Hill-Ferguson Rectal 2.2 X 6.4CM Blade 8" Black Coated

Speculum, Non-Illuminated

Ambler Surgical

Barr self-retaining anal retractor, 8'', 2 3/4'' deep x 7/8'' wide blades, ring handle with ratchet catch

Speculum, Non-Illuminated

MSI Precision Specialty Instruments

Hinkle-James Rectal Speculum, Tapered From 16mm To 51mm (5/8" To 2"), Overall Length 4-3/8" (111mm)

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