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Rectoscope and proctoscope handles
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8834.90Model 10000201249
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rectoscope/proctoscope handle FDA UDI
- Device Name
- Rectoscope and proctoscope handles EUDAMEDRECTOSCOPE-HANDLE with cold light illumination, reusable FDA UDI
- Model / Reference
- 10000201249 EUDAMED8834.90 EUDAMED883490 FDA UDI
- Description
- RECTOSCOPE-HANDLE with cold light illumination, reusable FDA UDI
Identifiers
- Catalog Number
- 8834.90 FDA UDI
- Primary DI / UDI-DI
- 04055207011218 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018216P3 EUDAMED
- Direct Marketing DI
- 04055207011218 EUDAMED
- FDA Product Code
- NBH FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Rectoscope/proctoscope handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1100 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
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 | 405520727052019-0018216P3 | 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 fc0c8025-fdd4-4c2a-939f-212db61a3f5e 61 fields · synced Jun 18, 2026
- FDA UDI 2f4a0ebb-0a76-4e2d-a7f0-6fc5ee76e881 36 fields · synced May 30, 2026