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Tigsun AMH Antigen Rapid Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 20 testsModel 50 testsModel 1 testModel 10 testsModel 80 testsModel 5 testsModel 25 tests
Identity
- Device Name
- Tigsun AMH Antigen Rapid Test (FIA) EUDAMED
- Model / Reference
- 20 tests EUDAMEDN/A EUDAMED50 tests EUDAMED1 test EUDAMED10 tests EUDAMED80 tests EUDAMED5 tests EUDAMED25 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381605 EUDAMED06973642381636 EUDAMED06973642381575 EUDAMED06973642381599 EUDAMED06973642381643 EUDAMED06973642381582 EUDAMED06973642381612 EUDAMED
- Basic UDI-DI
- B-06973642381605 EUDAMEDB-06973642381636 EUDAMEDB-06973642381575 EUDAMEDB-06973642381599 EUDAMEDB-06973642381643 EUDAMEDB-06973642381582 EUDAMEDB-06973642381612 EUDAMED
- EMDN Code
- W0102050215 ANTI-MULLERIAN HORMONE 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 AMH 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-06973642381605 | 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 (7)
- EUDAMED b9d4f6d3-7343-4707-9848-41448bb0276c 61 fields · synced Aug 1, 2026
- EUDAMED 5faf0f69-3a55-43cc-a892-cdaea6933bb9 61 fields · synced May 16, 2026
- EUDAMED c8d167e2-04ab-45a2-ba27-6d8143acd9ef 61 fields · synced May 17, 2026
- EUDAMED da6d718a-be5f-4e31-8fcd-e202ba9884bc 61 fields · synced May 17, 2026
- EUDAMED 0128cb65-1dfd-4b05-b24f-5949cbd9feca 61 fields · synced May 18, 2026
- EUDAMED f60deb19-a0f5-4fef-98b3-8408e39d695a 61 fields · synced May 18, 2026
- EUDAMED ba338768-7a3b-431a-aaf2-08f9b410ab47 61 fields · synced May 18, 2026