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Reusable Temperature Probe
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref W0001BRef W0001CModel W0001ARef W0001DRef W0013C
Identity
- Trade Name
- Reusable Temperature Probe EUDAMEDMED-LINK FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Reusable Temperature Probe EUDAMED
- Model / Reference
- W0001B EUDAMEDFDA UDIW0001A EUDAMEDW0001C EUDAMEDW0001D EUDAMEDW0013C EUDAMED
Identifiers
- Catalog Number
- W0001B FDA UDI
- Primary DI / UDI-DI
- 06944414006910 EUDAMEDFDA UDI06944414096270 EUDAMED06944414055758 EUDAMED06944414091954 EUDAMED06944414078351 EUDAMED06944414069335 EUDAMED06944414095112 EUDAMED06944414069427 EUDAMED06944414069373 EUDAMED06944414045971 EUDAMED06944414069410 EUDAMED06944414002240 EUDAMED06944414091978 EUDAMED
- Basic UDI-DI
- 69444140102SM EUDAMED69444140101SK EUDAMED
- 510(k) Number
- K182667 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMEDV03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb 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
No
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
EUDAMEDEUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Reusable Temperature Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193338 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69444140102SM | Class IIa | Active |
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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 091e7334-beda-44aa-8db5-4184ea16443d 61 fields · synced Aug 2, 2026
- FDA UDI c38a43a0-739a-4b5d-9fef-9106b5c28731 34 fields · synced May 30, 2026
- EUDAMED 46a3d70a-c723-44e9-afc7-4cbb3e822d42 61 fields · synced Jun 19, 2026
- EUDAMED 4422e441-a032-4910-80c6-103a0a0535c8 61 fields · synced Jul 9, 2026
- EUDAMED ef60c66f-6b3c-4fc7-805c-57b4320af701 61 fields · synced Jul 9, 2026
- EUDAMED 7e0cee3a-257e-4068-8d6b-587fe30a4d8b 61 fields · synced Jul 11, 2026
- EUDAMED 90932dc4-2a7f-4234-b472-45bd60272876 61 fields · synced Jul 13, 2026
- EUDAMED 0c4dfc99-e035-4eae-ace7-bd9493a61074 61 fields · synced Jul 14, 2026
- EUDAMED ca08463c-cef1-4e03-ad06-bacbbd51fbad 61 fields · synced Jul 15, 2026
- EUDAMED 696a40a7-abba-49a0-9059-96cd90125fe8 61 fields · synced Jul 19, 2026
- EUDAMED 162c6572-db6d-4416-8eb4-7c3413b3e946 61 fields · synced Jul 28, 2026
- EUDAMED 5fdee462-a68d-46d1-a7e4-54244570ceda 61 fields · synced Jul 28, 2026
- EUDAMED bad77632-2240-4510-b6a4-867fa54547a8 61 fields · synced Aug 1, 2026
- EUDAMED 4913a258-acd7-46f9-8aa5-4cdbdc8109e3 61 fields · synced Aug 2, 2026
- FDA 510(k) K193338 1 fields · synced Jun 9, 2026