Identity
- Trade Name
- Accu-Beam F35 Endoscope Coupler EUDAMEDAccu-Beam FDA UDI
- Generic Name
- Endoscope camera adaptor FDA UDI
- Device Name
- Accu-Beam Endoscopic Video Adaptors EUDAMED35mm focal length Endoscopic Coupler. Insulated. FDA UDI
- Model / Reference
- 8013I EUDAMEDFDA UDI
- Description
- 35mm focal length Endoscopic Coupler. Insulated. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1778013I0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B177125V EUDAMED
- Direct Marketing DI
- B1778013I0 EUDAMED
- FDA Product Code
- FWL FDA UDI
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Endoscope camera adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 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
No
FDA UDI
Hydrogen Peroxide FDA UDI
Accu-Beam F35 Endoscope Coupler by Transamerican Technologies International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++B177125V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Transamerican Technologies International
- EUDAMED SRN
- US-MF-000007955
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED 3b462678-8b20-4f0d-a214-c9bb55712822 61 fields · synced Jun 18, 2026
- FDA UDI 6beb8c82-6664-40f4-900a-ffefd9bab385 33 fields · synced May 30, 2026