← Back to catalogue
Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1：2×15 mL、R2：2×4.2 mLRef R1：1×15 mL、R2：1×4.2 mLRef 2×120 Tests/kitRef 120 Tests/kit
Identity
- Device Name
- Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1：2×15 mL、R2：2×4.2 mL EUDAMEDR1：1×15 mL、R2：1×4.2 mL EUDAMED2×120 Tests/kit EUDAMED120 Tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977568200095 EUDAMED06977568200088 EUDAMED06977568200118 EUDAMED06977568200101 EUDAMED
- Basic UDI-DI
- B-06977568200095 EUDAMEDB-06977568200088 EUDAMEDB-06977568200118 EUDAMEDB-06977568200101 EUDAMED
- EMDN Code
- W0102019009 CALPROTECTIN 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 Calprotectin 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-06977568200095 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Cavan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000052933
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (4)
- EUDAMED 1b793d22-fb21-4a25-b8e4-39df43a060b6 61 fields · synced Oct 6, 2026
- EUDAMED b92804dc-f178-4954-8ec6-d22337c69b07 61 fields · synced May 18, 2026
- EUDAMED fecd05cb-6d5b-4133-a942-7ae30c7c59eb 61 fields · synced May 18, 2026
- EUDAMED f09c41ae-a845-4ebb-8a7e-eb9c6e0be653 61 fields · synced May 19, 2026