Identity
- Trade Name
- CAPILLARYS / MINICAP URINE EUDAMED
- Device Name
- CAPILLARYS / MINICAP URINE EUDAMED
- Model / Reference
- 2013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360020135 EUDAMED
- Basic UDI-DI
- 3607362013BUAY EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Capillarys / Minicap Urine by Sebia — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080916 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 3607362013BUAY | Class A | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED 82a41be1-b132-4e78-9a07-18d57d66c6da 61 fields · synced Jul 25, 2026
- FDA 510(k) K080916 1 fields · synced May 18, 2026