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Transanal Endoscopic Microsurgery
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8840.047Model 10000201290
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Transanal Endoscopic Microsurgery EUDAMEDTEM OBTURATOR Ø 36MM WL 255MM WL 255mm, reusable FDA UDI
- Model / Reference
- 10000201290 EUDAMED8840.047 EUDAMED8840047 FDA UDI
- Description
- TEM OBTURATOR Ø 36MM WL 255MM WL 255mm, reusable FDA UDI
Identifiers
- Catalog Number
- 8840.047 FDA UDI
- Primary DI / UDI-DI
- 04055207043608 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520718022019-0018343KA EUDAMED
- Direct Marketing DI
- 04055207043608 EUDAMED
- FDA Product Code
- FJL FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscope obturator 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
Dimensions & Sizes
- Size
- Length — 255 Millimeter FDA UDIOuter Diameter — 36 Millimeter FDA UDI
Transanal Endoscopic Microsurgery 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 | 405520718022019-0018343KA | 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 be84e65b-0f83-407b-8abf-a7af53b4e879 61 fields · synced Jul 16, 2026
- FDA UDI 0e946d4c-d264-434b-b9e6-b2e90791843b 36 fields · synced May 30, 2026