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FREND COVID-19 Ag
EUDAMEDClass IVD General (EU MDR)
Ref FRCOG-J 020PModel FREND COVID-19 AgRef FRCOG-F 020PRef FRCOG 020PRef FRECOG-F 020P
Identity
- Trade Name
- FREND COVID-19 Ag EUDAMED
- Device Name
- FRCOG-J 020P EUDAMEDFRCOG-F 020P EUDAMEDFRCOG 020P EUDAMED
- Model / Reference
- FREND COVID-19 Ag EUDAMEDFRCOG-J 020P EUDAMEDFRCOG-F 020P EUDAMEDFRCOG 020P EUDAMEDFRECOG-F 020P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317541136 EUDAMED08809317541112 EUDAMED08809317541129 EUDAMED
- Basic UDI-DI
- B-08809317541136 EUDAMEDB-08809317541112 EUDAMEDB-08809317541129 EUDAMED
- EMDN Code
- W0105040619 EUDAMEDW0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
FREND COVID-19 Ag 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-08809317541136 | 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 (6)
- EUDAMED ad112936-10f3-415d-a7b9-712fcdd361a1 61 fields · synced Jul 18, 2026
- EUDAMED 9d655aa4-951c-4dcf-86a0-d62299b16592 61 fields · synced May 18, 2026
- EUDAMED b1abf9f3-2802-47b1-9691-65b66fef5550 61 fields · synced May 18, 2026
- EUDAMED 57ad6040-216e-4d6f-bceb-d20edd1c94a2 61 fields · synced Jul 15, 2026
- EUDAMED f5776bb4-d4dc-4b45-a302-1a3a35bac00a 61 fields · synced Jul 17, 2026
- EUDAMED 6a9eea66-680f-44d5-ae7a-71ace8716bfe 61 fields · synced Jul 18, 2026