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ASI IVD System V 8.4
EUDAMEDFDA UDIClass A (EU MDR)
Ref FPRSF0107 - 10 and FPRSF0118Model ASI IVD System
Identity
- Trade Name
- ASI IVD System V 8.4 EUDAMEDASI IVD System FDA UDI
- Generic Name
- Laboratory analyser operation system software IVD FDA UDI
- Device Name
- ASI IVD System BandView, ASI IVD System FISHView, ASI IVD System MetScan EUDAMEDASI IVD System with software version GenASIs V-8.4 FDA UDI
- Model / Reference
- ASI IVD System EUDAMEDFPRSF0107 - 10 and FPRSF0118 EUDAMEDGenASIs 8.4 FDA UDI
- Description
- ASI IVD System with software version GenASIs V-8.4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016630046 EUDAMEDFDA UDI
- Basic UDI-DI
- 0729001663003T3 EUDAMED
- FDA Product Code
- JOY FDA UDINOT FDA UDINQN FDA UDILNJ FDA UDINTH FDA UDI
- EMDN Code
- W0202050392 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Laboratory analyser operation system software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5260 FDA UDI864.1860 FDA UDI866.4700 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ASI IVD System V 8.4 by Applied Spectral Imaging Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0729001663003T3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED a0c9a191-c2f9-4226-9e44-a0e1fd2ba99e 61 fields · synced Jul 28, 2026
- FDA UDI f74a6653-2df2-4232-a033-325394446e92 33 fields · synced May 29, 2026