Identity
- Device Name
- SimplexTAS 101 Heating Block EUDAMED
- Model / Reference
- T0001002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800037900104 EUDAMED
- Basic UDI-DI
- 880003790010AY EUDAMED
- EMDN Code
- W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
SimplexTAS 101 Heating Block by tascom co., ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 880003790010AY | Class A | 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 6485475c-0d3a-4caf-b198-5024ed2c9823 61 fields · synced Jul 25, 2026