← Back to catalogue
13Respiratory Pathogen Multiplex Detection Kit (PCR Capillary Electrophoresis F…
EUDAMEDClass IVD General (EU MDR)
Ref 1060091
Identity
- Device Name
- 13Respiratory Pathogen Multiplex Detection Kit (PCR Capillary Electrophoresis Fragment Analysis) EUDAMED
- Model / Reference
- 1060091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500057 EUDAMED
- Basic UDI-DI
- B-06937044500057 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
13Respiratory Pathogen Multiplex Detection Kit (PCR Capillary Electrophoresis F… by Ningbo HEALTH Gene Technologies Co., LTD. — Class IVD General — IVDD…
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-06937044500057 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ae525492-5252-4ae4-a392-94f7021a1841 61 fields · synced Aug 3, 2026