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Resectoscope tubes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8834.085Model 10000201233
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical rectoscope, reusable FDA UDI
- Device Name
- Resectoscope tubes EUDAMEDRECTOSCOPE TUBE Ø 12.5MM WL 212MM WL 212mm, TL 256mm, straight, reusable FDA UDI
- Model / Reference
- 10000201233 EUDAMED8834.085 EUDAMED8834085 FDA UDI
- Description
- RECTOSCOPE TUBE Ø 12.5MM WL 212MM WL 212mm, TL 256mm, straight, reusable FDA UDI
Identifiers
- Catalog Number
- 8834.085 FDA UDI
- Primary DI / UDI-DI
- 04055207043370 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018183PD EUDAMED
- Direct Marketing DI
- 04055207043370 EUDAMED
- FDA Product Code
- GCM FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Rigid optical rectoscope, 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
- Not 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 12.5 Millimeter FDA UDILength — 212 Millimeter FDA UDI
Resectoscope tubes 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 | 405520727052019-0018183PD | 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 b3bfb652-79a4-4113-814d-bfefa3cc3635 61 fields · synced Jun 19, 2026
- FDA UDI 865f0f19-d7cb-41da-b6bc-ce35e54ddf43 37 fields · synced May 30, 2026