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Tigsun COVID-19 Saliva Antigen Rapid Test (LolliSwab)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 40 testsModel 80 testsModel 5 testsModel 25 testsModel 50 testsModel 20 testsModel 100 testsModel 10 tests
Identity
- Device Name
- Tigsun COVID-19 Saliva Antigen Rapid Test (LolliSwab) EUDAMED
- Model / Reference
- 40 tests EUDAMEDN/A EUDAMED80 tests EUDAMED5 tests EUDAMED25 tests EUDAMED50 tests EUDAMED20 tests EUDAMED100 tests EUDAMED10 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382862 EUDAMED06973642382886 EUDAMED06973642380028 EUDAMED06973642382855 EUDAMED06973642382879 EUDAMED06973642382848 EUDAMED06973642382893 EUDAMED06973642382831 EUDAMED
- Basic UDI-DI
- B-06973642382862 EUDAMEDB-06973642382886 EUDAMEDB-06973642380028 EUDAMEDB-06973642382855 EUDAMEDB-06973642382879 EUDAMEDB-06973642382848 EUDAMEDB-06973642382893 EUDAMEDB-06973642382831 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tigsun COVID-19 Saliva Antigen Rapid Test (LolliSwab) by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06973642382862 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Tigsun Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000034480
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED 963bc4a5-d772-4c49-911a-c1ace49455d3 61 fields · synced Jul 30, 2026
- EUDAMED f9469b84-9530-4d38-8545-17829309a824 61 fields · synced May 17, 2026
- EUDAMED 067f97d9-4c80-4499-a8bb-5fb9706076ac 61 fields · synced May 17, 2026
- EUDAMED 0812ef86-0e54-42d7-8a10-ac4c31801d4b 61 fields · synced May 17, 2026
- EUDAMED ea0fe7be-701a-4c20-84ca-03b7fb69088e 61 fields · synced May 17, 2026
- EUDAMED 3df569ab-05f3-43b0-91d1-edc58fc4e285 61 fields · synced May 18, 2026
- EUDAMED d4f38699-bd3f-43a2-8d45-464ccf8cdca0 61 fields · synced May 18, 2026
- EUDAMED 17ab7558-5672-48a5-9e8f-c70f6dbc41ce 61 fields · synced May 19, 2026