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Terason uSmart3300 USB3
EUDAMEDClass IIa (EU MDR)
Ref 10-3303 R2Model Terason uSmart3300 USB3
Identity
- Trade Name
- Terason uSmart3300 USB3 EUDAMED
- Device Name
- uSmart3300 Ultrasound System USB3 EUDAMED
- Model / Reference
- Terason uSmart3300 USB3 EUDAMED10-3303 R2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852698007225 EUDAMED
- Basic UDI-DI
- 852698007225JH EUDAMED
- Direct Marketing DI
- 00852698007225 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS 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 uSmart3300 USB3 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 | 852698007225JH | 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 dc173548-6c86-46b8-893e-f8e71184aaed 61 fields · synced Jun 19, 2026