Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Optical proctoscope, reusable FDA UDI
- Device Name
- Proctoscope tubes EUDAMEDPROCTOSCOPE TUBE Ø 24MM WL 60MM WL 60mm, TL 75mm, straight, reusable FDA UDI
- Model / Reference
- 10000201238 EUDAMED8836.085 EUDAMED8836085 FDA UDI
- Description
- PROCTOSCOPE TUBE Ø 24MM WL 60MM WL 60mm, TL 75mm, straight, reusable FDA UDI
Identifiers
- Catalog Number
- 8836.085 FDA UDI
- Primary DI / UDI-DI
- 04055207043530 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018189PR EUDAMED
- Direct Marketing DI
- 04055207043530 EUDAMED
- FDA Product Code
- GCM FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Optical proctoscope, 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 — 24 Millimeter FDA UDILength — 60 Millimeter FDA UDI
Proctoscope 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 | 405520727052019-0018189PR | 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 8611823c-df48-4252-b6ca-e5bde36153ae 61 fields · synced Jun 19, 2026
- FDA UDI 4f23d845-3cd6-4b64-840e-7c489cb87a80 37 fields · synced May 30, 2026