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69361558covid19-Ag-Be**x5
EUDAMEDClass IVD General (EU MDR)
Ref ITP16013-TC25-Model ITP16013
Identity
- Trade Name
- 69361558COVID19-AG-BE**X5 EUDAMED
- Device Name
- Rapid SARS-CoV-2 Antigen Test EUDAMED
- Model / Reference
- ITP16013 EUDAMEDITP16013-TC25- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155808359 EUDAMED
- Basic UDI-DI
- B-06936155808359 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
69361558covid19-Ag-Be**x5 by InTec PRODUCTS, 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-06936155808359 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- InTec PRODUCTS, INC.
- EUDAMED SRN
- CN-MF-000023625
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED c0dc95cd-80b9-4d61-ad33-6e7e5d4076ef 61 fields · synced Jul 9, 2026