Microlab STAR IVD-R
by Hamilton Bonaduz AG United States EUDAMEDGUDID
Ref 185080
Product code JQWEMDN W02060199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0763003261850807U | Date24 May 2022 | StatusActive |
| United States | GUDID listing GUDID | Number07630032600010 | Date3 Dec 2014 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Microlab STAR IVD-R EUDAMEDStar Compl. with Access. GUDID
- Generic Name
- Pipetting system
- Model / Reference
- 185080
- Primary DI / UDI-DI
- 07630032600010
- Basic UDI-DI
- 0763003261850807U, 76300326185080LN
- Direct Marketing DI
- 07630032600010
- FDA Product Code
- JQW
- EMDN Code
- W02060199 Robotic sample processing systems - other
- GMDN Term
- Pipetting system
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2750
- Market of Registration
- GermanyAustria
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- CH-MF-000013585
- Authorised representative
- Johner Medical GmbH DE-AR-000011832
Other devices from Hamilton Bonaduz AG
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (3)
- EUDAMED dbe4cd4c-d771-4170-8ef2-e309243fc686
- FDA UDI 3f77d74e-b9c1-4060-9a5a-3a838e676067
- EUDAMED 07630032600010|76300326185080LN