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Kinetik
EUDAMEDClass I (EU MDR)
Ref IET 3PCModel IET2PC/IET3PCRef ET-100ERef ET-100A
Identity
- Trade Name
- Kinetik EUDAMED
- Device Name
- Disposable probe covers EUDAMEDInfrared Ear Thermometer EUDAMED
- Model / Reference
- IET2PC/IET3PC EUDAMEDIET 3PC EUDAMEDET-100E EUDAMEDET-100A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931562701231 EUDAMED06931562702962 EUDAMED16931562702822 EUDAMED
- Basic UDI-DI
- 69315627ET-01J7 EUDAMEDB-06931562702962 EUDAMEDB-16931562702822 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMEDV0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kinetik by Hangzhou Hua'an Medical & Health Instruments Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69315627ET-01J7 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69315627ET-01J7 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013858
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 21d908b5-b6ca-49a6-a3b2-ccd64e7d940b 61 fields · synced Oct 6, 2026
- EUDAMED 124df115-99f4-4e4d-9c48-4e2535666f92 61 fields · synced May 18, 2026
- EUDAMED ea17ac0d-f4e0-4c91-aa2a-8358020142e2 61 fields · synced May 19, 2026