XEVO TQ-S micro IVD
by Waters Corporation United States EUDAMEDGUDID
Ref 186007833IVD
Product code DOPEMDN W020303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number081677602MSTKPF0802BU | Date4 Oct 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00816776020179 | Date5 Oct 2021 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- XEVO TQ-S micro IVD EUDAMEDXevo GUDID
- Generic Name
- Mass spectrometry analyser IVD
- Device Name
- Waters IVD Systems
- Model / Ref / Catalog
- 186007833IVD
- Primary DI / UDI-DI
- 00816776020179
- Basic UDI-DI
- 081677602MSTKPF0802BU
- Direct Marketing DI
- 00816776020179
- FDA Product Code
- DOP
- EMDN Code
- W020303 Mass - spectrometry system
- GMDN Term
- Mass spectrometry analyser IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2860
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000025801
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Waters Corporation
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 (2)
- EUDAMED 1496de18-26e4-4e4e-b4c8-2ece6c7db2f0
- FDA UDI 39b3bf97-44b6-4e3a-b5c9-14bed11f4fb6