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Electrolytes Quality Control （ISE method）
EUDAMEDClass A (EU MDR)
Ref AFT-ISEQC（R1/R2/R3）Model AFT-ISEQC: R1: Electrolytes Quality Control（High Level）1.0ml; R2: Electrolytes Quality Control（Middle Level）1.0ml; R3: Electrolytes Quality Control（Low Level）1.0ml.
Identity
- Device Name
- Electrolytes Quality Control （ISE method） EUDAMED
- Model / Reference
- AFT-ISEQC: R1: Electrolytes Quality Control（High Level）1.0ml; R2: Electrolytes Quality Control（Middle Level）1.0ml; R3: Electrolytes Quality Control（Low Level）1.0ml. EUDAMEDAFT-ISEQC（R1/R2/R3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947929531069 EUDAMED
- Basic UDI-DI
- 69479295AFT-ISEQCS9 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
Electrolytes Quality Control （ISE method） 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-ISEQCS9 | 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 6315ddaa-6699-4221-bd22-df4ca29e8b9f 61 fields · synced Jun 18, 2026