← Back to catalogue
Minisono L3-12
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Minisono L3-12Model Minisono
Identity
- Trade Name
- Minisono L3-12 EUDAMEDminisono FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Minisono C1-6 EUDAMED
- Model / Reference
- Minisono EUDAMEDMinisono L3-12 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800013530004 EUDAMEDFDA UDI
- Basic UDI-DI
- 0880001357400RM EUDAMED
- Direct Marketing DI
- 08800013530004 EUDAMED
- FDA Product Code
- ITX FDA UDIIYN 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
- 892.1570 FDA UDI892.1550 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 L3-12 by Alpinion Medical Systems 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 | 0880001357400RM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alpinion Medical Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000012961
- Authorised Representative
- Alpinion Medical Deutschland GmbH DE-AR-000008603
Sources (2)
- EUDAMED 65096c2b-48ac-42d1-91df-ee9a9d4113d8 61 fields · synced Jun 18, 2026
- FDA UDI 47fdb970-e9c6-4162-8c89-10c040623848 32 fields · synced May 27, 2026