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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 SL030101SST-XRef SL030101
Identity
- Trade Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMEDCOVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva EUDAMED
- Device Name
- COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) EUDAMEDCOVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva EUDAMED
- Model / Reference
- SL030101NST-X EUDAMEDSL030101SST-X EUDAMEDSL030101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062769323 EUDAMED06952062770060 EUDAMED06952062772750 EUDAMED06952062772774 EUDAMED06952062770213 EUDAMED06952062774112 EUDAMED06952062769347 EUDAMED06952062769293 EUDAMED
- Basic UDI-DI
- B-06952062769323 EUDAMEDB-06952062770060 EUDAMEDB-06952062772750 EUDAMEDB-06952062772774 EUDAMEDB-06952062770213 EUDAMEDB-06952062774112 EUDAMEDB-06952062769347 EUDAMEDB-06952062769293 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
- Spain EUDAMEDGermany EUDAMEDFinland EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
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-06952062769323 | 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 54704c7a-dd2d-446e-bd7d-6a0f693b7305 61 fields · synced Oct 10, 2026
- EUDAMED 796c6b5a-4231-4838-98ef-8b8a27dc9c1e 61 fields · synced May 16, 2026
- EUDAMED d709fdc1-0330-4b71-bf7b-d0df05e40cb4 61 fields · synced May 16, 2026
- EUDAMED b03a2a38-38ec-4a9d-a99e-ea76c1435761 61 fields · synced May 17, 2026
- EUDAMED 63a889a4-65af-4fb5-9975-2566a75ceb5c 61 fields · synced May 17, 2026
- EUDAMED 88143308-dbe0-4e77-bf8f-13f67783c4dd 61 fields · synced May 17, 2026
- EUDAMED d29e1aa7-2049-4dc2-ab71-da0dd656afc1 61 fields · synced May 18, 2026
- EUDAMED 9b3f1098-a200-4952-821e-9ce6b2b6592b 61 fields · synced May 19, 2026