Identity
- Trade Name
- ST3303 EUDAMED
- Device Name
- Temperature Probe EUDAMED
- Model / Reference
- ST3303 EUDAMED07-10-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972820961066 EUDAMED
- Basic UDI-DI
- B-06972820961066 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
St3303 by Shenzhen SINO-K Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06972820961066 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen SINO-K Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000021157
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 33148872-10b1-4598-b777-6baa43fba99b 61 fields · synced Jul 25, 2026