Identity
- Trade Name
- AmCAD-US EUDAMED
- Model / Reference
- US-0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875622014 EUDAMED
- Basic UDI-DI
- 471987562201US6G EUDAMED
- EMDN Code
- Z12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AmCAD-US by Amcad Biomed Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987562201US6G | 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 (1)
- EUDAMED dc0e3be5-9ea2-4c16-b8c6-3fed37d62307 61 fields · synced Jun 19, 2026