← Back to catalogue
Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 2000264Model FS
Identity
- Device Name
- Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- FS EUDAMED2000264 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360198 EUDAMED
- Basic UDI-DI
- B-06975578360198 EUDAMED
- EMDN Code
- W0105070202 BLOOD STREAM INFECTION/SEPSIS (BACTERIA & 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
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
Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method) by Pilot Gene Technology (Hangzhou) 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-06975578360198 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 8c1ace57-a5f4-4fdc-979e-916027713007 61 fields · synced Jul 21, 2026