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SimplexTAS 101 HbA1c Reagent Cartridge
EUDAMEDClass IVD General (EU MDR)
Ref T0101002
Identity
- Device Name
- SimplexTAS 101 HbA1c Reagent Cartridge EUDAMED
- Model / Reference
- T0101002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800037900944 EUDAMED
- Basic UDI-DI
- B-08800037900944 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SimplexTAS 101 HbA1c Reagent Cartridge by tascom co., ltd. — Class IVD General — 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-08800037900944 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- tascom co., ltd.
- EUDAMED SRN
- KR-MF-000019000
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 2939ffff-5ccd-4b97-9deb-ebe5d68cfd22 61 fields · synced Jun 18, 2026