Identity
- Trade Name
- Terason 15WL4 EUDAMED
- Device Name
- 15WL4 (50mm) Linear Wide Transducer EUDAMED
- Model / Reference
- Terason EUDAMED10-3390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852698007522 EUDAMED
- Basic UDI-DI
- 852698007522JS EUDAMED
- Direct Marketing DI
- 00852698007522 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 15WL4 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 | 852698007522JS | 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 adfce537-ec76-4779-9d1e-adc068744084 61 fields · synced Jun 19, 2026