Identity
- Trade Name
- Terason XY EUDAMED
- Device Name
- XY Transducer EUDAMED
- Model / Reference
- Terason XY EUDAMED10-3363 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852698007539 EUDAMED
- Basic UDI-DI
- 852698007539KB EUDAMED
- Direct Marketing DI
- 00852698007539 EUDAMED
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Terason XY by Teratech Corporation — 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 | 852698007539KB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teratech Corporation
- EUDAMED SRN
- US-MF-000033295
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 01230079-5f27-441f-95fa-62473a8b4a46 61 fields · synced Jul 9, 2026