Identity
- Trade Name
- ST5105A EUDAMEDSINO-K FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Temperature Probe EUDAMEDSkin contact Temperature Probe, adult, disposable FDA UDI
- Model / Reference
- ST5105A EUDAMEDFDA UDI07-10-00 EUDAMED
- Description
- Skin contact Temperature Probe, adult, disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972820961288 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06972820961288 EUDAMED
- 510(k) Number
- K223807 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose patient temperature probe, reusable
St5105a by Shenzhen SINO-K Medical Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972820961288 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED af749ddb-0abd-4f07-9919-d2d247f7561d 61 fields · synced Jul 23, 2026
- FDA UDI 90e433fa-9467-40df-a35f-0297b76345e4 34 fields · synced May 30, 2026