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NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 303036-05
Identity
- Device Name
- NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing EUDAMED
- Model / Reference
- 303036-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412611874 EUDAMED
- Basic UDI-DI
- B-06972412611874 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing by Hangzhou Laihe Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD…
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-06972412611874 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a39f8036-e3f7-44bf-9d9f-d29c092ba312 61 fields · synced Jul 20, 2026