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Fully Automated Fecal Immunochemical Test Analyzer
EUDAMEDClass A (EU MDR)
Ref FIT-1000Model FIT-1000/1200/1600/1800
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-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977568200019 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 (1)
- EUDAMED d6e2952c-b3ed-4cdd-b8b7-f9add7b3ea4e 61 fields · synced Oct 5, 2026