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Aco Smartcare
EUDAMEDClass IIa (EU MDR)
Ref Aco-Apa-L154Model C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3HRef Aco-Apa-C62Ref Aco-Apa-iOSModel Apache App iOS, Apache App Android
Identity
- Trade Name
- Aco Smartcare EUDAMED
- Device Name
- Aco Apache Ultrasound Probe EUDAMED
- Model / Reference
- C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H EUDAMEDAco-Apa-L154 EUDAMEDAco-Apa-C62 EUDAMEDApache App iOS, Apache App Android EUDAMEDAco-Apa-iOS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719890960023 EUDAMED04719890960016 EUDAMED04719890960092 EUDAMED
- Basic UDI-DI
- 471989096ApacheDU EUDAMED471989096ApacheAppLM EUDAMED
- Direct Marketing DI
- 04719890960023 EUDAMED04719890960016 EUDAMED
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMEDZ11040192 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 | 471989096ApacheDU | 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 (3)
- EUDAMED fe5bbbeb-c12b-4711-9784-076040327b69 61 fields · synced Jul 26, 2026
- EUDAMED a54c9681-0b4b-4081-8a0e-c1770d8d6c51 61 fields · synced May 18, 2026
- EUDAMED b0432141-adba-4734-a2a7-ae23c5be97ee 61 fields · synced May 19, 2026