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Gynecological handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8986.251Model 10000201341
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Device Name
- Gynecological handles EUDAMEDHANDLE FOR HYSTEROSCOPE compatible with sheath system for diagnostic hysteroscopy, bayonet-cap, reusable FDA UDI
- Model / Reference
- 10000201341 EUDAMED8986.251 EUDAMED8986251 FDA UDI
- Description
- HANDLE FOR HYSTEROSCOPE compatible with sheath system for diagnostic hysteroscopy, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8986.251 FDA UDI
- Primary DI / UDI-DI
- 04055207023662 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018447PQ EUDAMED
- Direct Marketing DI
- 04055207023662 EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- L059099 OBSTETRICS AND GYNECOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gynecological handles by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 405520727052019-0018447PQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 7de21fc6-4ec1-4a3a-bf2c-e3310e71b272 61 fields · synced Jun 19, 2026
- FDA UDI b2ee4800-d7df-457b-8dba-43acada7b39e 35 fields · synced May 30, 2026