Identity
- Trade Name
- Ultrasound Fetal transducer EUDAMED
- Device Name
- Ultrasound Fetal transducer EUDAMED
- Model / Reference
- FUSTC-GD02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691973317 EUDAMED
- Basic UDI-DI
- B-06941691973317 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Our Ultrasound Fetal transducer is a cutting-edge device designed for accurate and precise medical imaging of fetal development. With its advanced technology and user-friendly interface, it offers unparalleled diagnostic capabilities in prenatal care.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941691973317 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (1)
- EUDAMED 31a91acd-159b-491d-92f5-aada3f29dacd 61 fields · synced Jul 22, 2026