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Blood Gas Refill Solution
EUDAMEDClass A (EU MDR)
Ref BEF15（R5:for pCO2 ）Model BEF11
Identity
- Device Name
- Blood Gas Refill Solution EUDAMED
- Model / Reference
- BEF11 EUDAMEDBEF15（R5:for pCO2 ） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929599786 EUDAMED
- Basic UDI-DI
- 69479295BEF7X EUDAMED
- EMDN Code
- W0201040185 BLOOD GAS ANALYSERS - CONSUMABLES 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
Blood Gas Refill Solution 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 | 69479295BEF7X | 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 (1)
- EUDAMED 253e5501-3fcc-43e8-8adc-6870ed9d1b25 61 fields · synced Jun 17, 2026