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cornley
EUDAMEDClass A (EU MDR)
Ref AFT-ISEC6，0.8mlModel AFT-ISEC，0.8ml 、AFT-ISEC6，0.8ml 、AFT-ISEC8，0.8mlRef 10.10.220010Model MINI I, MINI II
Identity
- Trade Name
- cornley EUDAMED
- Device Name
- Conditioning Solution EUDAMEDCalibration standard solution EUDAMED
- Model / Reference
- AFT-ISEC，0.8ml 、AFT-ISEC6，0.8ml 、AFT-ISEC8，0.8ml EUDAMEDAFT-ISEC6，0.8ml EUDAMEDMINI I, MINI II EUDAMED10.10.220010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929501352 EUDAMED06947929500805 EUDAMED
- Basic UDI-DI
- 69479295AFT-ISECAK EUDAMED69479295MINIR5P EUDAMED
- EMDN Code
- W0201040185 BLOOD GAS ANALYSERS - CONSUMABLES EUDAMEDW01010399 ELECTROLYTES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
cornley by Meizhou Cornley Hi-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69479295AFT-ISECAK | Class A | Active |
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Manufacturer
- Manufacturer
- Meizhou Cornley Hi-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025014
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED d3421c80-982c-4936-924b-35773aa43e0d 61 fields · synced Jul 10, 2026
- EUDAMED 50c780b1-b820-4c4f-93dd-662ab91fb716 61 fields · synced May 19, 2026