Wasp
by Copan Wasp S.r.l. Italy EUDAMEDGUDID
Ref W086 Product code JTCEMDN W02060101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number58059796363506 | Date21 Nov 2024 | StatusIn distribution |
| European Union | CE/IVDR EUDAMED | Number805014821IP020AAUTOM01SH | Date20 Dec 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Generic Name
- Microbial specimen inoculation/streaking/colony-picking instrument IVD
- Device Name
- WASP System
- Model / Ref / Catalog
- W086
- Primary DI / UDI-DI
- 58059796363506
- Basic UDI-DI
- 805014821IP020AAUTOM01SH
- FDA Product Code
- JTC
- EMDN Code
- W02060101 Automated systems for the management of pre and post-analysis
- GMDN Term
- Microbial specimen inoculation/streaking/colony-picking instrument IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 866.2500
- Market of Registration
- Italy
- Commercial Distribution
- 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 7dda5bc9-99cf-4ceb-9538-1e0fa30abb7c
- FDA UDI 8ebf9fba-6c8b-4ec0-b332-ad2ea2e3153b