Dilator, Urethral

Which Manufacturers in China Make This?

4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Zhejiang.

Jiana Sterilization Technology (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Seplou (Zhuhai) Co., Ltd. Guangdong
Well Lead Medical Co., Ltd. Guangdong, contract manufacturer
Zhejiang Chuangxiang Medical Technology Co., Ltd. Zhejiang, contract manufacturer

How Is KOE Classified?

Dilator, Urethral is FDA product code KOE, Class 2, 21 CFR 876.5520.

How Does It Reach the US Market?

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 Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2005. None was by a company in China. The root cause the FDA records most often is Process control (2).

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

Dilator, Urethral

Medtronic Disposable Inflation Device

Inflation Device Atrion Part Number 96473: 14mL, 30atm

Dilator, Urethral

Tracoe Technic® Disposable Inflation Device

Inflation Device Atrion Part Number 96492: 25mL, 30atm

Dilator, Urethral

Meatal Dilator Adult

Meatal Dilator Adult: 1 catalogue number listed by Allwin Medical Devices, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Olympus EndoTherapy™ Inflation Device for Endoscopic Balloon Dilation

Inflation Device Atrion Part Number 96379: 60mL, 15atm

Dilator, Urethral

Uro-EZDilate KIT 18fr (6mm) X 4cm Ureteral Balloon Dilation Catheter

Catalogue number BURS0604K, listed by Gyrus Acmi, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Single Use Urethral Dilator

Catalogue number MD-S-UD-0840, listed by Zhejiang Chuangxiang Medical Technology Co., Ltd., China, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Councill

Councill Catheter

Dilator, Urethral

Excel Medical Products Disposable Inflation Device

Catalogue number QL® 2030, listed by Atrion Medical Products, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Olympus EndoTherapy™ Inflation Device for Biliary

Inflation Device Atrion Part Number 96296: 20mL, 15atm

Dilator, Urethral

Meatal Dilator Pediatric

Meatal Dilator Pediatric: 1 catalogue number listed by Allwin Medical Devices, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Tunner

Tunner Pediatric Urethral Dilator Set

Dilator, Urethral

MED Pro Medical B.V.

Meatal Dilator 6/16

Dilator, Urethral

Bard® Urologist’s Tray

Catalogue number 123400, listed by C.R. Bard, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Bard® Heyman™ Slipover Catheter Stylet

Catalogue number 042900, listed by C.R. Bard, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Flexor Parallel

Flexor, Parallel Rapid Release Ureteral Access Sheath with AQ, Hydrophilic Coating

Dilator, Urethral

Everis, Inflation Device

Inflation Device Atrion Part Number 96532: 60mL, 15atm

Dilator, Urethral

Atala-Shepard

Atala-Shepard Coaxial Balloon Follower With AQ, Hydrophilic Long Taper Urethral Dilators

Dilator, Urethral

Solace™

20CC-30ATM Inflation Device

Dilator, Urethral

S~Curve

S-Curve Urethral Dilator Set With AQ, Hydrophilic Coating

Dilator, Urethral

SwitchBack™

14CC-55ATM Inflation Device

Dilator, Urethral

CRE SteriFlate Disposable Inflation Device

Inflation Device Atrion Part Number 96477: 60mL, 15atm

Dilator, Urethral

ConMed Inflation Device

Catalogue number QL® 6015, listed by Atrion Medical Products, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Panmed|u.s. Pan|medical Disposable Inflation Device

Inflation Device: 14mL, 55atm

Dilator, Urethral

Atala-Steinbock

Atala-Steinbock Balloon Follower

Dilator, Urethral

LB Medical Disposable Inflation Device

Inflation Device: 10mL, 20atm

Dilator, Urethral

Vascular Medical Disposable Inflation Device

Catalogue number QL2030PR, listed by Atrion Medical Products, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Stryker AVA/iVAS® Inflator

Inflation Device Atrion Part Number 96493: 14mL, 400psi

Dilator, Urethral

Angiodynamics Namic Disposable Inflation Device

Inflation Device Atrion Part Number 96468: 20mL, 30atm

Dilator, Urethral

Ace Medical Company

Medpro Meatal Dilator Size 6/16(fr) sterile- Box -10 (Ref# MD6/16)

Dilator, Urethral

Optilume Basic Urological Dilation Catheter

The Optilume Basic Urological Balloon Dilation Catheter widens narrowed segments of the urethra. It is an over the wire catheter compatible with a 0.038 inch guidewire and the working…

Dilator, Urethral

UroMax Ultra

11 catalogue numbers from M0062251080, listed by Boston Scientific Corporation, United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Micro-Tech QL® 6015 Inflation Device

Catalogue number QL® 6015, listed by Atrion Medical Products, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Sphere™ Inflation Device

Inflation Device Atrion Part Number 96364A: 40mL, 15atm

Dilator, Urethral

Atrion QL4515 Inflation Device

Inflation Device Atrion Part Number 96530: 45mL, 15atm

Dilator, Urethral

QL Disposable Inflation Device

Inflation Device Atrion Part Number 96460: 25mL, 30atm

Dilator, Urethral

Bard® Polyurethane Ureteral Catheters, Spiral Tip

Catalogue number 137904, listed by C.R. Bard, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Bard® Polyurethane Ureteral Catheters, Olive Tip

Catalogue number 136904, listed by C.R. Bard, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

V. Mueller

V. Mueller WALTHER DILATOR-CATHETER FEMALE, MIRROR FINISH, 32FR. OVERALL LENGTH 5-3/4 inches 14.5CM

Dilator, Urethral

Aeris Inflation Device

Catalogue number QL2530, listed by Atrion Medical Products, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Wellead Urethral Dilator

Urethral Dilator Set Straight, Hydrophilic coated 8-24Fr

Dilator, Urethral

EZDilate

Uro-EZDilate KIT 15Fr (5mm) X 10cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE

Dilator, Urethral

Flexor

Flexor, DL Dual Lumen Ureteral Access Sheath with AQ, Coating

Dilator, Urethral

Stryker Interventional Spine iVAS™ Inflator

Inflation Device: 14mL, 30atm

Dilator, Urethral

UroMax Ultra Kit

Balloon Dilatation Catheter Kit

Dilator, Urethral

Dilator, Urethral

TELESCOPE DILATOR 18FR for nephrostomy, in particular for dilating transcutaneous punctures, TL 230 mm, reusable

Dilator, Urethral

Seplou

6 catalogue numbers from SPUD0124S, listed by Seplou (Zhuhai) Co., Ltd., China, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Bard® Eagle® Inflation Device

2 catalogue numbers from 325110, listed by C.R. Bard, Inc., United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.

Dilator, Urethral

Cook

Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper

Dilator, Urethral

Peel-Away

Peel-Away, Introducer Set

Dilator, Urethral

Amplatz

Amplatz Radiopaque TFE Sheath Use with 28 FR Amplatz dilator

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