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Refill Solution
EUDAMEDClass A (EU MDR)
Ref AFT-ISE（R2:for reference）Model AFT-ISE（R1:for K+,Na+,Cl-,Ca2+,pH）Ref AFT-ISE(R1:for K + ,Na + ,Cl -,Ca 2+ ,pH)Model AFT-ISERef AFT-ISE(R2:for reference)
Identity
- Device Name
- Refill Solution EUDAMED
- Model / Reference
- AFT-ISE（R1:for K+,Na+,Cl-,Ca2+,pH） EUDAMEDAFT-ISE（R2:for reference） EUDAMEDAFT-ISE EUDAMEDAFT-ISE(R1:for K + ,Na + ,Cl -,Ca 2+ ,pH) EUDAMEDAFT-ISE(R2:for reference) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929500102 EUDAMED06947929500096 EUDAMED
- Basic UDI-DI
- 69479295AFT-ISE2M EUDAMED
- EMDN Code
- W0201040185 BLOOD GAS ANALYSERS - CONSUMABLES EUDAMEDW0101070302 ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS 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
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 | 69479295AFT-ISE2M | 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 (5)
- EUDAMED 5c95d5f7-ad4d-4964-bb84-c35e3a2b9496 61 fields · synced Jul 10, 2026
- EUDAMED 64ecc129-c44a-4958-a1de-297d242f37a9 61 fields · synced May 18, 2026
- EUDAMED 64ecc129-c44a-4958-a1de-297d242f37a9-1 61 fields · synced Jun 10, 2026
- EUDAMED 6db94bf6-0863-44ef-8eb9-b8fa8d448528-1 61 fields · synced Jun 19, 2026
- EUDAMED 7528a12a-02f0-471c-ac6f-8279755c32b5 61 fields · synced Jul 10, 2026