← Back to catalogue
Reusable Temperature Probe
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref W0002C510(k) K182667
Identity
- Trade Name
- Reusable Temperature Probe EUDAMED
- Device Name
- Reusable Temperature Probe EUDAMED
- Model / Reference
- W0002C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414015301 EUDAMED
- Basic UDI-DI
- B-06944414015301 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Reusable Temperature Probe by Shenzhen Med-link Electronics Tech Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as General-purpose patient temperature probe, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- TRUWAVE — Edwards Lifesciences LLC · Class II
- MED-LINK — Shenzhen Med-Link Electronics Tech Co., Ltd. · Class II
- LIFEPAK 15 monitor/defibrillator — PHYSIO-CONTROL, Inc.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182667 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06944414015301 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 (2)
- EUDAMED 64e3a9f1-210a-473c-9245-a2d138edfc3d 85 fields · synced Jun 19, 2026
- FDA 510(k) K182667 1 fields · synced May 18, 2026