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PTH Parathyroid Hormone (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref PTH706-AE10Y, PTH706-AE10N, PTH706-AE20Y, PTH706-AE20N
Identity
- Trade Name
- PTH Parathyroid Hormone (CLIA) EUDAMED
- Device Name
- PTH Parathyroid Hormone (CLIA) EUDAMED
- Model / Reference
- PTH706-AE10Y, PTH706-AE10N, PTH706-AE20Y, PTH706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PTH706-AE8N EUDAMED
- Basic UDI-DI
- B-PTH706-AE8N EUDAMED
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT 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
PTH Parathyroid Hormone (CLIA) 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-PTH706-AE8N | 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 (2)
- EUDAMED 912038b2-9e6e-4fb8-8c9a-06cbc14624d9 61 fields · synced Jul 13, 2026
- EUDAMED 912038b2-9e6e-4fb8-8c9a-06cbc14624d9-1 61 fields · synced Jun 10, 2026