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free β-HCG Calibrators
EUDAMEDClass IVD General (EU MDR)
Ref EIM4282002Ref EIM4283002
Identity
- Device Name
- free β-HCG Calibrators EUDAMED
- Model / Reference
- EIM4282002 EUDAMEDEIM4283002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EIM4282002GY EUDAMEDD-EIM4283002H7 EUDAMED
- Basic UDI-DI
- B-EIM4282002GY EUDAMEDB-EIM4283002H7 EUDAMED
- EMDN Code
- W0102152202 HORMONE STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
free β-HCG Calibrators by Maccura Biotechnology 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-EIM4282002GY | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b3d2966c-6175-4b05-8ded-2a8dcfc0b774 61 fields · synced Oct 5, 2026
- EUDAMED 5a69aaa1-7da1-47fd-9328-8886d5d119a3 61 fields · synced May 18, 2026