Rossmax
by Tyson Bioresearch, Inc. 5 variants
Ref BGM_TS_007_RMModel Rossmax HS200
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-T05H1690077ANQQ D-T05H1690077ANQQ | Date27 Sep 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Rossmax HS200 Blood Glucose Test Strips
- Model / Reference
- Rossmax HS200, BGM_TS_007_RM
- Primary DI / UDI-DI
- D-T05H1690077ANQQ
- Basic UDI-DI
- B-T05H1690077ANQQ
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class IVD Annex II List B
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- TW-MF-000027508
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Tyson Bioresearch, Inc.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No