Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Pin-indexed adaptor, reusable FDA UDI
- Device Name
- Adapters EUDAMEDADAPTER FOR CYSTOSCOPE TL 79mm, compatible with sheaths 86520145, 86520245, 86520345, 86520445, and telescopes Ø 4mm, 0°/12°/30°/70°, with introduction port, bayonet-cap, reusable FDA UDI
- Model / Reference
- 10000201175 EUDAMED8652.264 EUDAMED8652264 FDA UDI
- Description
- ADAPTER FOR CYSTOSCOPE TL 79mm, compatible with sheaths 86520145, 86520245, 86520345, 86520445, and telescopes Ø 4mm, 0°/12°/30°/70°, with introduction port, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8652.264 FDA UDI
- Primary DI / UDI-DI
- 04055207018521 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520714102019-0017842CP EUDAMED
- Direct Marketing DI
- 04055207018521 EUDAMED
- FDA Product Code
- FBO FDA UDI
- EMDN Code
- L060413 ENDOSCOPIC UROLOGY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Pin-indexed adaptor, 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 | 405520714102019-0017842CP | 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 6bf23444-3892-44b4-96f0-947a4d7621f9 61 fields · synced May 30, 2026
- FDA UDI d65ae891-00fb-4342-8891-6cc45458351f 35 fields · synced May 30, 2026