WASPLab
by Copan Wasp S.r.l. Italy EUDAMEDGUDID
Ref W087
Product code JQPEMDN W02039099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number805014821IP040AAUTOM01UB | Date20 Dec 2021 | StatusActive |
| United States | GUDID listing GUDID | Number58050148212060 | Date27 Apr 2021 | StatusListed |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Microbial incubator/imaging system IVD
- Device Name
- WASPLab System
- Model / Ref / Catalog
- W087
- Primary DI / UDI-DI
- 58050148212060
- Basic UDI-DI
- 805014821IP040AAUTOM01UB
- FDA Product Code
- JQP, JTQ
- EMDN Code
- W02039099 Various microbiology instruments - other
- GMDN Term
- Microbial incubator/imaging system IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2100, 866.2540
- Market of Registration
- Italy
- Commercial Distribution
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- IT-MF-000012489
Other devices from Copan Wasp S.r.l.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- 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
- Professional 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 a9f7dc18-cdd4-4270-bf8c-147413b762ca
- FDA UDI 16188414-efb7-4c5d-93b3-4982532b0e59