Identity
- Trade Name
- QPLEX EUDAMED
- Device Name
- QPLEX™ COVID-19 Test EUDAMED
- Model / Reference
- QMCOVID02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800044300089 EUDAMED
- Basic UDI-DI
- B-08800044300089 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General 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
Qplex 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-08800044300089 | 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 (1)
- EUDAMED ad85dab3-7f34-4f4b-8bc2-dc934ec2db84 61 fields · synced Jun 18, 2026