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Quik-Check U500 Urine Analyzer
EUDAMEDClass A (EU MDR)
Ref U211-117-201Ref U211-107-201
Identity
- Trade Name
- Quik-Check U500 Urine Analyzer EUDAMED
- Device Name
- U500 Urine Analyzer EUDAMED
- Model / Reference
- U211-117-201 EUDAMEDU211-107-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26921756496382 EUDAMED26921756496375 EUDAMED
- Basic UDI-DI
- 6921756499990024X3 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 U500 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 | 6921756499990024X3 | 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 (2)
- EUDAMED be641d0c-8003-4b33-a5ac-f09abc65f904 61 fields · synced Oct 6, 2026
- EUDAMED cd1645eb-0000-4ef8-8eb0-6b2635193088 61 fields · synced May 16, 2026