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Quik-Check Expert U120 Smart Urine Analyzer
EUDAMEDClass A (EU MDR)
Ref U118-101-201
Identity
- Trade Name
- Quik-Check Expert U120 Smart Urine Analyzer EUDAMED
- Device Name
- Expert U120 Smart Urine Analyzer EUDAMED
- Model / Reference
- U118-101-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26921756496436 EUDAMED
- Basic UDI-DI
- 6921756499990025X5 EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Quik-Check Expert U120 Smart Urine Analyzer by Acon Biotech (Hangzhou) 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 | 6921756499990025X5 | Class A | 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 1b66082a-5d36-4e33-ade8-474bfd471cca 61 fields · synced Jun 19, 2026