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Vancomycin-Resistant Enterococcus Gene (vanA, vanB) Detection Kit (PCR Fluoresc…
EUDAMEDClass IVD General (EU MDR)
Ref 106-0142-01Model 12 reactions/kit
Identity
- Device Name
- Vancomycin-Resistant Enterococcus Gene (vanA, vanB) Detection Kit (PCR Fluorescence) EUDAMED
- Model / Reference
- 12 reactions/kit EUDAMED106-0142-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447582201 EUDAMED
- Basic UDI-DI
- B-06975447582201 EUDAMED
- EMDN Code
- W0104080604 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE 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
Yes
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
Vancomycin-Resistant Enterococcus Gene (vanA, vanB) Detection Kit (PCR Fluoresc… by Igenesis(Shanghai)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-06975447582201 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6a427e9f-68e0-426d-ad59-8bf982f85115 61 fields · synced Jul 9, 2026