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Fully Automated Fecal Immunochemical Test Analyzer
EUDAMEDClass A (EU MDR)
Ref FIT-1200Model FIT-1000/1200/1600/1800Ref FIT-1600
Identity
- Trade Name
- Fully Automated Fecal Immunochemical Test Analyzer EUDAMED
- Device Name
- Fully Automated Fecal Immunochemical Test Analyzer EUDAMED
- Model / Reference
- FIT-1000/1200/1600/1800 EUDAMEDFIT-1200 EUDAMEDFIT-1600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977568200163 EUDAMED06977568200170 EUDAMED
- Basic UDI-DI
- 697756820FIT-EQSV EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
New Device
No
EUDAMED
Fully Automated Fecal Immunochemical Test Analyzer by Shenzhen Cavan Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697756820FIT-EQSV | Class A | 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 (2)
- EUDAMED 665b7c95-7d25-4585-b6af-4e1d1cee3a4c 61 fields · synced Jul 15, 2026
- EUDAMED 71cdbdd5-e2a7-462e-ab92-11172d6cd00e 61 fields · synced May 19, 2026