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COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref SL030101NST-XRef SL030101
Identity
- Trade Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMED
- Device Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMED
- Model / Reference
- SL030101NST-X EUDAMEDSL030101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062772170 EUDAMED06952062772132 EUDAMED06952062772163 EUDAMED06952062772125 EUDAMED06952062772217 EUDAMED06952062772200 EUDAMED06952062772156 EUDAMED06952062772743 EUDAMED
- Basic UDI-DI
- B-06952062772170 EUDAMEDB-06952062772132 EUDAMEDB-06952062772163 EUDAMEDB-06952062772125 EUDAMEDB-06952062772217 EUDAMEDB-06952062772200 EUDAMEDB-06952062772156 EUDAMEDB-06952062772743 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDFinland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) by Anhui Deepblue Medical Technology Co., Ltd — Class IVD devices for self-testing — IVDD — listed in…
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-06952062772170 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (8)
- EUDAMED 62b7e484-6b82-4ff3-a980-cc602de627ca 61 fields · synced Oct 7, 2026
- EUDAMED c0cd874f-8eec-4912-87b5-f35f519c9f67 61 fields · synced May 17, 2026
- EUDAMED 79e5b3c6-11b2-44a5-8489-56762300c388 61 fields · synced May 17, 2026
- EUDAMED 2868140f-01e0-4290-8799-49a1047d076a 61 fields · synced May 17, 2026
- EUDAMED 4752ff15-22b3-469f-950c-8c474f61cb0a 61 fields · synced May 18, 2026
- EUDAMED c3788828-879c-4d12-bb94-c94c19acc60f 61 fields · synced May 19, 2026
- EUDAMED 2f9653af-cd9d-45c1-814b-cb4df5fd2425 61 fields · synced May 19, 2026
- EUDAMED d1b3ac7d-1763-4a05-a541-236d51030549 61 fields · synced May 19, 2026