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N-MID Osteocalcin (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510502Model 2×50TRef 0320510501Model 50 T Ref 0320510503Model 100 T
Identity
- Trade Name
- N-MID Osteocalcin (eCLIA) EUDAMED
- Device Name
- N-MID Osteocalcin (eCLIA) EUDAMED
- Model / Reference
- 2×50T EUDAMED0320510502 EUDAMED50 T EUDAMED0320510501 EUDAMED100 T EUDAMED0320510503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063942 EUDAMED06975984063935 EUDAMED06975984063959 EUDAMED
- Basic UDI-DI
- B-06975984063942 EUDAMEDB-06975984063935 EUDAMEDB-06975984063959 EUDAMED
- EMDN Code
- W0102060311 OSTEOCALCINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
N-MID Osteocalcin (eCLIA) by Shenzhen Lifotronic 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-06975984063942 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 4ae742c5-adbd-4813-b851-a23e3bcf2b2f 61 fields · synced Jul 19, 2026
- EUDAMED 4d2048a7-bfbf-4536-9651-2d5bbb0fd758 61 fields · synced May 17, 2026
- EUDAMED defe13a8-75fe-4dde-99dd-00deeceaeb37 61 fields · synced May 19, 2026