Identity
- Device Name
- FT3 Calibrators EUDAMED
- Model / Reference
- EIM4282053 EUDAMEDEIM4283053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EIM4282053HH EUDAMEDD-EIM4283053HQ EUDAMED
- Basic UDI-DI
- B-EIM4282053HH EUDAMEDB-EIM4283053HQ EUDAMED
- EMDN Code
- W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
FT3 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-EIM4282053HH | 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 4c88e72f-0b55-4fd7-aa7c-191bb9b3c225 61 fields · synced Oct 6, 2026
- EUDAMED 0c57d2c7-6337-443e-9b2c-e82a2f093a6c 61 fields · synced May 19, 2026