Identity
- Trade Name
- ultrasonic transducer EUDAMED
- Device Name
- ultrasonic transducer EUDAMED
- Model / Reference
- SC6-1Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413828995 EUDAMED
- Basic UDI-DI
- 69444138UTGG EUDAMED
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Extracorporeal ultrasound imaging transducer, hand-held
ultrasonic transducer by Edan Instruments, Inc. — Class IIa — CE/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 | 69444138UTGG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1b7edb37-6f7e-4dd2-b7a9-dfb9d8f83ec5 61 fields · synced Oct 6, 2026