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Aichek
EUDAMEDClass IVD General (EU MDR)
Ref ATPO706-AE10Y, ATPO706-AE10N, ATPO706-AE20Y, ATPO706-AE20N
Identity
- Trade Name
- Aichek EUDAMEDA-TPO Antibody to Thyroid Peroxidase (CLIA) EUDAMED
- Device Name
- A-TPO Antibody to Thyroid Peroxidase (CLIA) EUDAMED
- Model / Reference
- ATPO706-AE10Y, ATPO706-AE10N, ATPO706-AE20Y, ATPO706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ATPO706-AE79 EUDAMED
- Basic UDI-DI
- B-ATPO706-AE79 EUDAMED
- EMDN Code
- W01020499 THYROID HORMONES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Aichek by Hangzhou Aichek Medical Technology 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-ATPO706-AE79 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED aa011702-3f38-486b-a6ab-ec75b7d575ff 61 fields · synced Jun 19, 2026
- EUDAMED ace3950d-00ed-49d7-b1ba-6c33b930f892-1 61 fields · synced Jun 19, 2026
- EUDAMED ace3950d-00ed-49d7-b1ba-6c33b930f892-2 61 fields · synced Jun 19, 2026