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Aco Smartcare
EUDAMEDClass IIa (EU MDR)
Ref Aco-Apa-AndroidModel Apache App iOS, Apache App Android
Identity
- Trade Name
- Aco Smartcare EUDAMED
- Model / Reference
- Apache App iOS, Apache App Android EUDAMEDAco-Apa-Android EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719890960108 EUDAMED
- Basic UDI-DI
- 471989096ApacheAppLM EUDAMED
- EMDN Code
- Z11040192 ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden 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
Aco Smartcare by Aco Healthcare Co., Ltd. — 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 | 471989096ApacheAppLM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aco Healthcare Co., Ltd.
- EUDAMED SRN
- TW-MF-000034057
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 709aab48-067e-4234-80f4-3c419fc67092 61 fields · synced Jun 17, 2026