← Back to catalogue
EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-base…
EUDAMEDClass IVD General (EU MDR)
Ref E011T050B0C1
Identity
- Device Name
- EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay) EUDAMED
- Model / Reference
- E011T050B0C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477116 EUDAMED
- Basic UDI-DI
- B-06970895477116 EUDAMED
- EMDN Code
- W0105040502 ENTEROVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-base… by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in…
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-06970895477116 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b0301b88-e5e9-45ac-b505-10659add8f4f 61 fields · synced Jun 19, 2026