Identity
- Trade Name
- ThinkQA Edition 2 EUDAMED
- Device Name
- ThinkQA Edition 2 EUDAMED
- Model / Reference
- TK2010, TK2020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B501THINKQA0200000 EUDAMED
- Basic UDI-DI
- ++B501THINKQA0200000RP EUDAMED
- Direct Marketing DI
- +B501THINKQA0200000 EUDAMED
- EMDN Code
- Z11019092 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ThinkQA Edition 2 by Dosisoft — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B501THINKQA0200000RP | Class I | Active |
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Manufacturer
- Manufacturer
- Dosisoft
- EUDAMED SRN
- FR-MF-000014706
Sources (1)
- EUDAMED 711c4893-03b1-4fb3-9a2a-24fa0cc14023 61 fields · synced May 22, 2026