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plusMED fasTTest
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref pM-100_CS_HighModel plusMED fasTTestRef pM-100_TS_50Ref pM-100_CS_Normal
Identity
- Trade Name
- plusMED fasTTest EUDAMED
- Device Name
- plusMED fasTTest Conrtol Solution EUDAMEDplusMED fasTTest Blood Glucose Test Strips EUDAMED
- Model / Reference
- plusMED fasTTest EUDAMEDpM-100_CS_High EUDAMEDpM-100_TS_50 EUDAMEDpM-100_CS_Normal EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-T05D5900003SNLH EUDAMEDD-T05D5900001ANJH EUDAMEDD-T05D5900001SNL7 EUDAMED
- Basic UDI-DI
- B-T05D5900003SNLH EUDAMEDB-T05D5900001ANJH EUDAMEDB-T05D5900001SNL7 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
plusMED fasTTest by Tyson Bioresearch, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-T05D5900003SNLH | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Tyson Bioresearch, Inc.
- EUDAMED SRN
- TW-MF-000027508
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED c0516602-80b9-443b-9e37-158bd646a34c 61 fields · synced Jul 27, 2026
- EUDAMED cd44f6a4-0574-45e3-96a5-044cae51acc7 61 fields · synced May 18, 2026
- EUDAMED 5a89f74e-7a4b-4b0d-8752-723aa00bb7b9 61 fields · synced May 19, 2026