GastroFinder® 2SMART
by PathoFinder B.V. Netherlands EUDAMED
Ref PF5600-2S EMDN W0105011099,W0105011499,W0105011606,W0105011899,W0105040501,W0105040506,W0105040516,W0105040530,W0105050201,W0105050208
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number87193271161PF5600-2SVQ | Date21 Feb 2023 | StatusWithdrawn |
| European Union | CE/IVDR | Number87193271161PF5600-2SVQ | Date21 Feb 2023 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD, CE/IVDR Withdrawn
Specification
- Model / Reference
- PF5600-2S
- Primary DI / UDI-DI
- 08719327116104
- Basic UDI-DI
- 87193271161PF5600-2SVQ, B-08719327116104
- Direct Marketing DI
- 08719327116104
- EMDN Code
- W0105011099,W0105011499,W0105011606,W0105011899,W0105040501,W0105040506,W0105040516,W0105040530,W0105050201,W0105050208
- Device Class
- Class BClass IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000002704
From the manufacturer
Manufacturer's product page: 2SmartFinder® technologySingle tube Multiplex Amplification in Real Time
Other devices from PathoFinder B.V.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 9adbb5eb-e990-4870-9366-b9b34a2990fe
- EUDAMED 08719327116104|B-08719327116104