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Rectoscope and proctoscope handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8838.90Model 10000201246
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rectoscope/proctoscope handle FDA UDI
- Device Name
- Rectoscope and proctoscope handles EUDAMEDPROCTO-RECTOSCOPE HANDLE with cold light illumination, reusable FDA UDI
- Model / Reference
- 10000201246 EUDAMED8838.90 EUDAMED883890 FDA UDI
- Description
- PROCTO-RECTOSCOPE HANDLE with cold light illumination, reusable FDA UDI
Identifiers
- Catalog Number
- 8838.90 FDA UDI
- Primary DI / UDI-DI
- 04055207011270 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018200NL EUDAMED
- Direct Marketing DI
- 04055207011270 EUDAMED
- FDA Product Code
- GCM FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Rectoscope/proctoscope handle 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
Rectoscope and proctoscope 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 | 405520727052019-0018200NL | 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 ca7f8847-96c9-484a-83f6-084edce8feb3 61 fields · synced Jul 20, 2026
- FDA UDI e2e1350f-39b6-433d-8fb2-ff35ffc617d6 36 fields · synced May 30, 2026