JANUS G3 Automated Workstation
by Revvity Health Sciences, Inc - MA United States EUDAMEDGUDID
Ref CJM4G01Model CJI4001 Product code JQWEMDN W02069099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number081258902JANUSG3H7 | Date3 Jun 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00812589020740 | Date20 Jan 2022 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- JANUS G3 Automated Workstation EUDAMEDJanus G3 GUDID
- Generic Name
- Pipetting system IVD
- Model / Reference
- CJI4001, CJM4G01
- Primary DI / UDI-DI
- 00812589020740
- Basic UDI-DI
- 081258902JANUSG3H7
- FDA Product Code
- JQW
- EMDN Code
- W02069099 Various sample processing instruments - other
- GMDN Term
- Pipetting system IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2750
- Market of Registration
- Finland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000023091
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Revvity Health Sciences, Inc - MA
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 2b6d8298-35d9-4a0c-809d-38488e1cf047
- FDA UDI b381956b-3de5-4cf9-8c2c-0a2e590f0ef5