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Minisono C1-6
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Minisono C1-6Model Minisono
Identity
- Trade Name
- Minisono C1-6 EUDAMEDminisono FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Minisono C1-6 EUDAMED
- Model / Reference
- Minisono EUDAMEDMinisono C1-6 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800013531001 EUDAMEDFDA UDI
- Basic UDI-DI
- 0880001357400RM EUDAMED
- Direct Marketing DI
- 08800013531001 EUDAMED
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Minisono C1-6 by Alpinion Medical Systems Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182845 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0880001357400RM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alpinion Medical Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000012961
- Authorised Representative
- Alpinion Medical Deutschland GmbH DE-AR-000008603
Sources (3)
- EUDAMED 41149f63-21a3-4b7f-b6ff-46b0fd9b5cde 61 fields · synced Oct 10, 2026
- FDA UDI 635bdff3-1eda-4945-bc71-69a43a320997 32 fields · synced May 30, 2026
- FDA 510(k) K182845 1 fields · synced May 18, 2026