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ASI IVD System HiPath IHCFamily
EUDAMEDClass IVD General (EU MDR)
Ref FPRSF0134Model ASI IVD System V 8.4
Identity
- Trade Name
- ASI IVD System HiPath IHCFamily EUDAMED
- Device Name
- HiPath IHCFamily EUDAMED
- Model / Reference
- ASI IVD System V 8.4 EUDAMEDFPRSF0134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FPRSF0134KP EUDAMED
- Basic UDI-DI
- B-FPRSF0134KP EUDAMED
- EMDN Code
- W0202050392 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
ASI IVD System HiPath IHCFamily by Applied Spectral Imaging Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-FPRSF0134KP | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Applied Spectral Imaging Ltd
- EUDAMED SRN
- IL-MF-000032463
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 80624158-ca12-4c48-933d-fdc887845df2 61 fields · synced Aug 1, 2026