Identity
- Trade Name
- AmCAD-US EUDAMED
- Device Name
- AmCAD-US EUDAMED
- Model / Reference
- US-0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875622007 EUDAMED
- Basic UDI-DI
- 471987562US3J EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AmCAD-US by Amcad Biomed Corporation — Class IIa — 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 | K162574 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471987562US3J | Class IIa | 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 e8ba7423-5bbf-4a64-914a-7d1ede828ffe 61 fields · synced Jun 19, 2026
- FDA 510(k) K162574 1 fields · synced May 18, 2026