Identity
- Trade Name
- Head & Neck Laser Alignment Tool EUDAMED
- Model / Reference
- UO-1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14719875623001 EUDAMED
- Basic UDI-DI
- 471987562LATS2 EUDAMED
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Head & Neck Laser Alignment Tool by Amcad Biomed Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180867 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471987562LATS2 | Class I | Active |
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Manufacturer
- Manufacturer
- AmCad BioMed Corporation
- EUDAMED SRN
- TW-MF-000013445
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 7b2c3671-417b-4900-b316-ec432beee171 61 fields · synced Aug 2, 2026
- FDA 510(k) K180867 1 fields · synced May 18, 2026