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Aco Smartcare
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Aco-Apa-neoP42Model C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H
Identity
- Trade Name
- Aco Smartcare EUDAMEDFDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Aco Apache Ultrasound Probe EUDAMEDThe Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes. FDA UDI
- Model / Reference
- C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H EUDAMEDAco-Apa-neoP42 EUDAMEDneo P42 FDA UDI
- Description
- The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719890960078 EUDAMEDFDA UDI
- Basic UDI-DI
- 471989096ApacheDU EUDAMED
- Direct Marketing DI
- 04719890960078 EUDAMED
- 510(k) Number
- K231509 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Aco Smartcare by Aco Healthcare Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471989096ApacheDU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aco Healthcare Co., Ltd.
- EUDAMED SRN
- TW-MF-000034057
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED d436abdd-bc4a-4cda-b32e-16cc99707d64 61 fields · synced Jul 21, 2026
- FDA UDI f699fb14-fbd5-4b21-8de2-b6ab0a7d782c 34 fields · synced May 30, 2026