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Infrared thermometer
EUDAMEDClass IIa (EU MDR)
Ref NC200 (PEMPA T200)Ref NC100(ORO-BABY COLOR)Model NC100（ORO-BABY COLOR）
Identity
- Trade Name
- Infrared thermometer EUDAMED
- Device Name
- Infrared thermometer EUDAMED
- Model / Reference
- NC200 (PEMPA T200) EUDAMEDNC100（ORO-BABY COLOR） EUDAMEDNC100(ORO-BABY COLOR) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158405244 EUDAMED06948158401031 EUDAMED
- Basic UDI-DI
- B-06948158405244 EUDAMEDB-06948158401031 EUDAMED
- EMDN Code
- V03010199 THERMOMETERS - OTHER EUDAMEDZ1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Infrared thermometer by Shenzhen Combei Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06948158405244 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 51a55494-b794-4fc8-92bf-fb7bc6d4d443 61 fields · synced Oct 6, 2026
- EUDAMED fc02be9f-a9e0-4997-a71e-2332faf3cf3e 61 fields · synced May 17, 2026