← Back to catalogue
COVID-19 IgG/IgM Control LQ
EUDAMEDClass IVD General (EU MDR)
Ref FIC-COLQModel COVID-19 IgG/IgM Control LQ
Identity
- Trade Name
- COVID-19 IgG/IgM Control LQ EUDAMED
- Device Name
- FIC-COLQ EUDAMED
- Model / Reference
- COVID-19 IgG/IgM Control LQ EUDAMEDFIC-COLQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540900 EUDAMED
- Basic UDI-DI
- B-08809317540900 EUDAMED
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. 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
COVID-19 IgG/IgM Control LQ 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-08809317540900 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED f54d321d-9819-4b6a-98c4-ee7ad349026e 61 fields · synced May 29, 2026