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ThinkQA Edition 2
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref TK2010, TK2020510(k) K180106
by Dosisoft
Identity
- Trade Name
- ThinkQA Edition 2 EUDAMED
- Device Name
- ThinkQA Edition 2 EUDAMED
- Model / Reference
- TK2010, TK2020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B501THINKQA0200020 EUDAMED+B501THINKQA0200010 EUDAMED
- Basic UDI-DI
- ++B501THINKQA0200000RP EUDAMED
- Direct Marketing DI
- +B501THINKQA0200020 EUDAMED+B501THINKQA0200010 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180106 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B501THINKQA0200000RP | Class I | Active |
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Manufacturer
- Manufacturer
- Dosisoft
- EUDAMED SRN
- FR-MF-000014706
Sources (4)
- EUDAMED 4cd72a66-cfda-4dc9-ba11-7d1297b13d2b 85 fields · synced Jul 21, 2026
- EUDAMED e175455d-5050-4891-a9cd-7e22ddc99f75 61 fields · synced May 17, 2026
- EUDAMED 4cd72a66-cfda-4dc9-ba11-7d1297b13d2b-1 61 fields · synced Jul 21, 2026
- FDA 510(k) K180106 1 fields · synced May 18, 2026