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β2-MG Quantitative Test Kit (Time-Resolved FIA)
EUDAMEDClass IVD General (EU MDR)
Ref FIMG-402a
Identity
- Trade Name
- β2-MG Quantitative Test Kit (Time-Resolved FIA) EUDAMED
- Device Name
- β2-MG Quantitative Test Kit (Time-Resolved FIA) EUDAMED
- Model / Reference
- FIMG-402a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FIMG-402a2T EUDAMED
- Basic UDI-DI
- B-FIMG-402a2T EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Beta-2-microglobulin IVD, reagent
β2-MG Quantitative Test Kit (Time-Resolved FIA) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
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- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
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-FIMG-402a2T | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d49ea129-6aa8-49d0-b1a2-c8964760a535 61 fields · synced Jul 25, 2026