Identity
- Trade Name
- Accu-Beam Universal Micromanipulator EUDAMEDAccu-Beam FDA UDI
- Generic Name
- Laser adaptor FDA UDI
- Device Name
- Accu-Beam CO₂ Laser Accessories EUDAMEDGeneral use micromanipulator for articulated arm CO2 lasers. FDA UDI
- Model / Reference
- 7004 EUDAMEDFDA UDI
- Description
- General use micromanipulator for articulated arm CO2 lasers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B17770040 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B177015Q EUDAMED
- 510(k) Number
- K864378 FDA UDI
- FDA Product Code
- HHR FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Laser adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4550 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Accu-Beam Universal Micromanipulator 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 | ++B177015Q | 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 fcd8960b-bc9b-4f1b-923c-b7bb46ab02b1 61 fields · synced Oct 6, 2026
- FDA UDI 975b3fa5-2a72-4b9b-9b91-d8fd497a6c41 34 fields · synced May 29, 2026