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Tigsun PIGF Antigen Rapid Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 1 testModel 10 testsModel 80 testsModel 100 testsModel 5 tests
Identity
- Device Name
- Tigsun PIGF Antigen Rapid Test (FIA) EUDAMED
- Model / Reference
- 1 test EUDAMEDN/A EUDAMED10 tests EUDAMED80 tests EUDAMED100 tests EUDAMED5 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381483 EUDAMED06973642381506 EUDAMED06973642381551 EUDAMED06973642381568 EUDAMED06973642381490 EUDAMED
- Basic UDI-DI
- B-06973642381483 EUDAMEDB-06973642381506 EUDAMEDB-06973642381551 EUDAMEDB-06973642381568 EUDAMEDB-06973642381490 EUDAMED
- EMDN Code
- W0102050211 PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA) 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 PIGF Antigen Rapid Test (FIA) by Beijing Tigsun Diagnostics Co., Ltd. — 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-06973642381483 | 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 (5)
- EUDAMED adb709a3-44e8-4b6e-af85-609ac0233f79 61 fields · synced Jul 17, 2026
- EUDAMED 74c3e6d1-be39-4658-b7ed-867dbbc5fbdb 61 fields · synced May 18, 2026
- EUDAMED 948f6fdc-a8cd-4c6d-8c11-5d60182a7533 61 fields · synced May 18, 2026
- EUDAMED 1978c1bd-6a48-4af1-b9cb-ba0080b22b25 61 fields · synced May 18, 2026
- EUDAMED d69ecf27-f9ff-455a-b6c8-67eda13b1fc3 61 fields · synced May 18, 2026