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Boiron Test ＆ Care Urine Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref A11024003Model 10 tests/KitRef A11024004Model 25 tests/Kit
Identity
- Trade Name
- Boiron Test ＆ Care Urine Test Strip EUDAMED
- Device Name
- Urine Test Strip EUDAMED
- Model / Reference
- 10 tests/Kit EUDAMEDA11024003 EUDAMED25 tests/Kit EUDAMEDA11024004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973861683191 EUDAMED06973861683207 EUDAMED
- Basic UDI-DI
- B-06973861683191 EUDAMEDB-06973861683207 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Boiron Test ＆ Care Urine Test Strip by Anbio (Xiamen) Biotechnology Co., Ltd. — Class IVD General — 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-06973861683191 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anbio (Xiamen) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023936
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 94128ef6-1f75-4349-8979-e90510f19bfe 61 fields · synced Jul 21, 2026
- EUDAMED 88cfae76-cde6-4ef5-b8d0-a56132eda162 61 fields · synced May 18, 2026