← Back to catalogue
Indicaid Covid-19 Rapid Antigen Test
EUDAMEDClass IVD General (EU MDR)
Ref 2110200
Identity
- Device Name
- INDICAID COVID-19 RAPID ANTIGEN TEST EUDAMED
- Model / Reference
- 2110200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897116730039 EUDAMED
- Basic UDI-DI
- B-04897116730039 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Indicaid Covid-19 Rapid Antigen Test by Phase Scientific International Limited — 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-04897116730039 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phase Scientific International Limited
- EUDAMED SRN
- HK-MF-000025791
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5e924ed3-a62b-47dc-9315-8686620babb4 61 fields · synced Jul 21, 2026