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Disposable Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref W0001FRef W0003FRef W0013F
Identity
- Trade Name
- Disposable Temperature Probe EUDAMEDMED-LINK FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Device Name
- Disposable Temperature Probe EUDAMED
- Model / Reference
- W0001F EUDAMEDFDA UDIW0003F EUDAMEDW0013F EUDAMED
Identifiers
- Catalog Number
- W0001F FDA UDI
- Primary DI / UDI-DI
- 06944414007115 EUDAMEDFDA UDI06944414076012 EUDAMED06944414099301 EUDAMED06944414097284 EUDAMED06944414076029 EUDAMED06944414076005 EUDAMED06944414095419 EUDAMED06944414095525 EUDAMED06944414095501 EUDAMED06944414077132 EUDAMED06944414044363 EUDAMED06944414095389 EUDAMED06944414069571 EUDAMED06944414047791 EUDAMED
- Basic UDI-DI
- 69444140107SX EUDAMED
- 510(k) Number
- K193338 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER 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
- Germany 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Temperature Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69444140107SX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011145
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (15)
- EUDAMED f2bed7e1-eee3-4144-b6cb-cd62384f10fc 61 fields · synced Aug 2, 2026
- FDA UDI 27542715-962f-44aa-8a82-f581f5704fb8 34 fields · synced May 29, 2026
- EUDAMED 650d0759-03d5-4b13-9166-db674869665d 61 fields · synced Jul 10, 2026
- EUDAMED 6eddf659-d3ef-4873-86e7-063f09d96c59 61 fields · synced Jul 10, 2026
- EUDAMED 129ac7e0-d522-43cf-a04a-fb5e1e73b090 61 fields · synced Jul 11, 2026
- EUDAMED 80dece09-9e7c-4eb0-b6fc-3852a7199041 61 fields · synced Jul 12, 2026
- EUDAMED b9edd23c-7c51-4990-a518-c61703706abc 61 fields · synced Jul 15, 2026
- EUDAMED 55c1bed4-4cf7-4e93-8672-35a4a6e63f4f 61 fields · synced Jul 15, 2026
- EUDAMED 7490c2fd-d081-4ada-b1c0-7c00115ab680 61 fields · synced Jul 20, 2026
- EUDAMED e6d89b48-8b73-4420-a238-f158caa49a3d 61 fields · synced Jul 21, 2026
- EUDAMED 51e9b35c-5a9f-4a3f-9e59-c523171adcfc 61 fields · synced Jul 24, 2026
- EUDAMED e59d6b52-2f0f-48c3-a85f-ae32d687cdad 61 fields · synced Jul 24, 2026
- EUDAMED a4b6696c-cc45-4728-be6b-33f06a85b861 61 fields · synced Jul 25, 2026
- EUDAMED 96c510cc-45ae-4553-ba60-740feb4720fc 61 fields · synced Jul 31, 2026
- EUDAMED 354188b0-2e2a-4ad2-bf87-fe5206568a5a 61 fields · synced Aug 2, 2026