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Accu-Answer
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref UricRef Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V
Identity
- Trade Name
- ACCU-ANSWER EUDAMED
- Device Name
- Urine Glucose Test Strips EUDAMEDUrinary Analysis Test Strips EUDAMED
- Model / Reference
- Uric EUDAMEDUric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-693748520-UGPD EUDAMEDD-693748520UX EUDAMED
- Basic UDI-DI
- B-693748520-UGPD EUDAMEDB-693748520UX EUDAMED
- EMDN Code
- W0101060201 URINE SINGLE TEST STRIPS (INCL. TABLETS) 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Accu-Answer by Guilin Zhonghui Technology Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-693748520-UGPD | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guilin Zhonghui Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038423
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED db4f5a3c-5f92-4e8e-8861-1b8e5e69fc99 61 fields · synced Aug 3, 2026
- EUDAMED 95d61331-de51-42c2-b28b-4f7884362870 61 fields · synced May 18, 2026
- EUDAMED 95d61331-de51-42c2-b28b-4f7884362870-1 61 fields · synced Jun 10, 2026