Identity
- Trade Name
- SHARK FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Adapters EUDAMEDSHARK ADAPTER FOR MORCESCOPE 24/26FR for 24Fr and 26Fr Shark outer sheaths and for working elements, endoscopes with standard closing plug, Snap-On lock, reusable FDA UDI
- Model / Reference
- 10000201127 EUDAMED8675026 EUDAMEDFDA UDI
- Description
- SHARK ADAPTER FOR MORCESCOPE 24/26FR for 24Fr and 26Fr Shark outer sheaths and for working elements, endoscopes with standard closing plug, Snap-On lock, reusable FDA UDI
Identifiers
- Catalog Number
- 8675026 FDA UDI
- Primary DI / UDI-DI
- 04055207019634 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017755PX EUDAMED
- Direct Marketing DI
- 04055207019634 EUDAMED
- FDA Product Code
- FBO FDA UDI
- EMDN Code
- L060413 ENDOSCOPIC UROLOGY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Adapters 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 | 405520727052019-0017755PX | 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 f8efcbfd-0916-4618-8f44-133dd3667e32 61 fields · synced Jul 27, 2026
- FDA UDI b94503d3-5b54-4a12-ab0e-8c48aaa11f0c 35 fields · synced May 29, 2026