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QMAC-dRAST
EUDAMEDClass IVD General (EU MDR)
Ref QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05
Identity
- Trade Name
- QMAC-dRAST EUDAMED
- Device Name
- QMAC-dRAST GN S17, QMAC-dRAST GP S17, QMAC-dRAST GN E19, QMAC-dRAST GP E19, QMAC-dRAST GN E22 EUDAMED
- Model / Reference
- QMdRASTN02, QMdRASTP02, QMdRASTN03, QMdRASTP03, QMdRASTN05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800044300065 EUDAMED
- Basic UDI-DI
- B-08800044300065 EUDAMED
- EMDN Code
- W0104080107,W0104080108 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
QMAC-dRAST by QuantaMatrix Inc. — 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-08800044300065 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- QuantaMatrix Inc.
- EUDAMED SRN
- KR-MF-000022784
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 818f7f72-680a-4ae7-a401-7986833840f8 61 fields · synced Jul 14, 2026
- EUDAMED 818f7f72-680a-4ae7-a401-7986833840f8-1 61 fields · synced Jun 10, 2026