Identity
- Trade Name
- AmCAD-UT EUDAMED
- Model / Reference
- UT-0222 EUDAMEDUT-0222-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875621239 EUDAMED
- Basic UDI-DI
- 471987562UT3L 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-UT by Amcad Biomed Corporation — Class IIa — 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 | 471987562UT3L | 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 (1)
- EUDAMED 3583f53b-f17a-46af-a4a2-78ed17ad9ed7 61 fields · synced May 20, 2026