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Temperature Sensor
EUDAMEDClass IIb (EU MDR)
Ref CM-M03-005Model CM-M03-001Ref CM-M03-002
Identity
- Trade Name
- Temperature Sensor EUDAMED
- Device Name
- Temperature Sensor EUDAMED
- Model / Reference
- CM-M03-001 EUDAMEDCM-M03-005 EUDAMEDCM-M03-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429081411 EUDAMED06945429081404 EUDAMED
- Basic UDI-DI
- 69454290CM001JT EUDAMED
- EMDN Code
- V03010299 BODY TEMPERATURE MONITORING PROBES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Temperature Sensor by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69454290CM001JT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3882c95c-34c2-4f3e-a62e-2ef957dda3c7 61 fields · synced Oct 6, 2026
- EUDAMED 2cd056b5-9af2-4f0a-a97f-37a13b558ddf 61 fields · synced May 19, 2026