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QUIK-CHECK Ultra Cholesterol Monitoring System
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref C111-5017Model CCM-101
Identity
- Trade Name
- QUIK-CHECK Ultra Cholesterol Monitoring System EUDAMED
- Device Name
- QUIK-CHECK Ultra Cholesterol Monitoring System EUDAMED
- Model / Reference
- CCM-101 EUDAMEDC111-5017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-C111-5017RT EUDAMED
- Basic UDI-DI
- B-C111-5017RT EUDAMED
- EMDN Code
- W0101060102,W010106010801,W0201069099 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
QUIK-CHECK Ultra Cholesterol Monitoring System by Acon Biotech (Hangzhou) Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-C111-5017RT | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4f8e3abd-db63-41f8-bfef-11155faa44fe 61 fields · synced Oct 6, 2026