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Wellead Urethral Dilator

FDA UDI

Class II (US FDA UDI)

by Well Lead Medical Co., Ltd

Identity

Trade Name
Wellead Urethral Dilator FDA UDI
Generic Name
Urethral dilator, single-use FDA UDI
Device Name
S shape Urethral Dilator Hydrophilic 26Fr FDA UDI
Model / Reference
U02A072610 FDA UDI
Description
S shape Urethral Dilator Hydrophilic 26Fr FDA UDI

Identifiers

Primary DI / UDI-DI
06936881102530 FDA UDI
FDA Product Code
KOE FDA UDI
GMDN Term
Urethral dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5520 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urethral dilator, single-use

Wellead Urethral Dilator by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral dilator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Well Lead Medical Co., Ltd

Sources (1)

  • FDA UDI 640ba7aa-2ae5-46f0-a107-bbeb4cbe63fd 33 fields · synced May 30, 2026