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En-swer™ COVID-19 RT-PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref EPCO19100Model En-swer™ COVID-19 RT- PCR Kit
Identity
- Trade Name
- En-swer™ COVID-19 RT-PCR Kit EUDAMED
- Device Name
- EPCO19100 EUDAMED
- Model / Reference
- En-swer™ COVID-19 RT- PCR Kit EUDAMEDEPCO19100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540856 EUDAMED
- Basic UDI-DI
- B-08809317540856 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
En-swer™ COVID-19 RT-PCR Kit by NanoEnTek, 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-08809317540856 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d15d3645-f237-4de7-a6f7-53313bdc0165 61 fields · synced Jul 10, 2026