Identity
- Trade Name
- E-LINE FDA UDI
- Generic Name
- Rigid endoscope working guide FDA UDI
- Device Name
- Working inserts EUDAMEDWORKING INSERT FOR CYSTOSCOPE 0/30/70 with Albarran-lever, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4mm, with 2 introduction ports, bayonet-cap, reusable FDA UDI
- Model / Reference
- 10000201172 EUDAMED8650.204 EUDAMED8650204 FDA UDI
- Description
- WORKING INSERT FOR CYSTOSCOPE 0/30/70 with Albarran-lever, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4mm, with 2 introduction ports, bayonet-cap, reusable FDA UDI
Identifiers
- Catalog Number
- 8650.204 FDA UDI
- Primary DI / UDI-DI
- 04055207018286 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017838Q4 EUDAMED
- Direct Marketing DI
- 04055207018286 EUDAMED
- FDA Product Code
- FBO FDA UDI
- EMDN Code
- U0999 UROGENITAL ENDOSCOPIC DEVICES - OTHER EUDAMED
- GMDN Term
- Rigid endoscope working guide 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
Working inserts 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 | 405520727052019-0017838Q4 | 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 03c4c333-565c-424e-b7b6-01c274653469 61 fields · synced Jul 9, 2026
- FDA UDI 07a3af29-7ea5-4707-8d5d-7d135eb30b8e 35 fields · synced May 30, 2026