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Full-Automatic Nuceic Acid Detection and Analyzer
EUDAMEDClass A (EU MDR)
Ref iFIND S8Model iFIND S2 、iFIND S4 、iFIND S8Ref iFIND S2
Identity
- Device Name
- Full-Automatic Nuceic Acid Detection and Analyzer EUDAMED
- Model / Reference
- iFIND S2 、iFIND S4 、iFIND S8 EUDAMEDiFIND S8 EUDAMEDiFIND S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795552003 EUDAMED06974795551983 EUDAMED
- Basic UDI-DI
- 697479555iFIND6K EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Full-Automatic Nuceic Acid Detection and Analyzer by RocGene (Xuzhou) Technology Limited — 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 | 697479555iFIND6K | Class A | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 6078007e-ff8c-4925-819c-dc3b0a414f37 61 fields · synced Jul 22, 2026
- EUDAMED 33dc9a47-a41f-4c8a-ad0b-820d16f9a2c4 61 fields · synced May 17, 2026