Identity
- Trade Name
- dRAST EUDAMED
- Device Name
- dRAST EUDAMED
- Model / Reference
- QMdRASTR02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800044300034 EUDAMED
- Basic UDI-DI
- 88000443dRASTT8 EUDAMED
- Direct Marketing DI
- 08800044300034 EUDAMED
- EMDN Code
- W0203010180,W0203010182 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
dRAST by QuantaMatrix Inc. — 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 | 88000443dRASTT8 | Class A | Active |
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Manufacturer
- Manufacturer
- QuantaMatrix Inc.
- EUDAMED SRN
- KR-MF-000022784
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED fcd50fa8-405e-427f-96f4-ed954c9c7201 61 fields · synced Jul 19, 2026