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Transanal Endoscopic Microsurgery
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8840.045Model 10000201291
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical rectoscope, reusable FDA UDI
- Device Name
- Transanal Endoscopic Microsurgery EUDAMEDTEM TUBE Ø 40MM WL 217MM WL 217mm, for 8840.22, slanted, reusable FDA UDI
- Model / Reference
- 10000201291 EUDAMED8840.045 EUDAMED8840045 FDA UDI
- Description
- TEM TUBE Ø 40MM WL 217MM WL 217mm, for 8840.22, slanted, reusable FDA UDI
Identifiers
- Catalog Number
- 8840.045 FDA UDI
- Primary DI / UDI-DI
- 04055207043592 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711032019-0018345AE EUDAMED
- Direct Marketing DI
- 04055207043592 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
- 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
- Outer Diameter — 40 Millimeter FDA UDILength — 217 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 | 405520711032019-0018345AE | 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 09e79f19-4376-431b-a2e6-22fbc69e7262 61 fields · synced May 30, 2026
- FDA UDI a4641db4-179f-47e7-ad97-c7b59e66f020 36 fields · synced May 30, 2026