MassTrak™
by Waters Corporation United States EUDAMED
Ref 186008441IVD
EMDN W0102060309
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number081677602VTDKIT0608D9 | Date15 Apr 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Masstrak™ Vitamin D Kit
- Model / Reference
- 186008441IVD
- Primary DI / UDI-DI
- 00816776020414
- Basic UDI-DI
- 081677602VTDKIT0608D9
- EMDN Code
- W0102060309 25-hydroxyvitamin d
- Device Class
- Class B
- Market of Registration
- Netherlands
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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 9f4ac695-5ea4-4fe6-b381-fbe8c18867fc