Identity
- Trade Name
- 4Sc-RS EUDAMED
- Device Name
- 4Sc-RS EUDAMED
- Model / Reference
- 5973383 EUDAMEDH48062AU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278985613 EUDAMED
- Basic UDI-DI
- 08406821BUG005927Q EUDAMED
- Direct Marketing DI
- 00195278985613 EUDAMED
- EMDN Code
- Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
4Sc-RS by GE Medical Systems CO. Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 08406821BUG005927Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 08f7ace5-b06a-443a-b482-9ab52e3663ec 61 fields · synced Jul 28, 2026