Identity
- Trade Name
- C1-6A-M EUDAMEDC1-6A EUDAMED
- Device Name
- Ultrasonic Transducer EUDAMED
- Model / Reference
- 3C-A EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868607814 EUDAMED06945868608200 EUDAMED
- Basic UDI-DI
- 69458686P1004QQ EUDAMED
- Direct Marketing DI
- 06945868607814 EUDAMED06945868608200 EUDAMED
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Extracorporeal ultrasound imaging transducer, hand-held
C1-6a-M by Sonoscape Medical Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69458686P1004QQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 44b61e9e-6aad-4cce-8609-188d25e3324a 61 fields · synced Oct 6, 2026
- EUDAMED f47b2bdc-0f13-45ef-918c-cd59b28aedae 61 fields · synced May 18, 2026