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Fecal Immunochemical Test Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1：2×15 mL、R2：2×4.2 mL
Identity
- Device Name
- Fecal Immunochemical Test Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1：2×15 mL、R2：2×4.2 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977568200033 EUDAMED
- Basic UDI-DI
- B-06977568200033 EUDAMED
- EMDN Code
- W0102039013 FECAL OCCULT BLOOD (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Fecal Immunochemical Test Assay Kit (Latex Immunoturbidimetric Method) by Shenzhen Cavan Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06977568200033 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Cavan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000052933
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED 34c49f3b-f594-4fb2-bf81-9476a19033b6 61 fields · synced Jun 18, 2026