dIFine P30
by Visia Lab S.r.l. Italy EUDAMEDGUDID
Ref FA30SPModel L-IFA
Product code JQWEMDN W02060199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number805930434SP30DS | Date12 Dec 2023 | StatusActive |
| United States | GUDID listing GUDID | Number08059304340123 | Date5 Jun 2023 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Microscope slide maker/stainer IVD
- Model / Reference
- L-IFA EUDAMEDFA30SP EUDAMEDdIFine P30 GUDID
- Primary DI / UDI-DI
- 08059304340123
- Basic UDI-DI
- 805930434SP30DS
- FDA Product Code
- JQW
- EMDN Code
- W02060199 Robotic sample processing systems - other
- GMDN Term
- Microscope slide maker/stainer IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2750
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | L-IFA FA30SP | dIFine P30 |
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- IT-MF-000013016
Other devices from Visia Lab S.r.l.
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (2)
- EUDAMED d601c93b-7b1e-42bc-ade5-0fa1d745d6f5
- FDA UDI ab975511-9e5b-48e4-aab1-aa42fac1e6dd