mahe medical GmbH

FDA UDI

Class II (US FDA UDI)

by mahe medical gmbh

Identity

Trade Name: mahe medical GmbH FDA UDI
Generic Name: Rigid endoscope obturator FDA UDI
Device Name: Urethrotome-obturator only, 21Ch. _x000D_ _x000D_ FDA UDI
Model / Reference: 37.006.03 FDA UDI
Description: Urethrotome-obturator only, 21Ch. _x000D_ _x000D_ FDA UDI

Identifiers

Primary DI / UDI-DI: 04050659373655 FDA UDI
FDA Product Code: JFL FDA UDI
GMDN Term: Rigid endoscope obturator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Rigid endoscope obturator

mahe medical GmbH by mahe medical gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SHARK — Richard Wolf GmbH · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: mahe medical gmbh

Sources (1)

FDA UDI eb52eca4-574b-4074-b50b-a4a4550ee20b 33 fields · synced May 31, 2026