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Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 10210107BModel 50 tests/kitRef 10210107AModel 10 tests/kit
Identity
- Device Name
- Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED10210107B EUDAMED10 tests/kit EUDAMED10210107A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795550573 EUDAMED06974795550566 EUDAMED
- Basic UDI-DI
- B-06974795550573 EUDAMEDB-06974795550566 EUDAMED
- EMDN Code
- W0105070201 GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method) by RocGene (Xuzhou) Technology Limited — 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-06974795550573 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 69fa8589-883f-44b4-bf18-323d85c9d4ef 61 fields · synced Aug 3, 2026
- EUDAMED 3e4078da-dce5-4413-bba1-2c0ad6ffac3d 61 fields · synced May 18, 2026