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IgE Quantitative Test Kit(Time-Resolved FIA)
EUDAMEDClass IVD General (EU MDR)
Ref FGIGE-302a
Identity
- Trade Name
- IgE Quantitative Test Kit(Time-Resolved FIA) EUDAMED
- Device Name
- IgE Quantitative Test Kit(Time-Resolved FIA) EUDAMED
- Model / Reference
- FGIGE-302a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FGIGE-302aW5 EUDAMED
- Basic UDI-DI
- B-FGIGE-302aW5 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
IgE Quantitative Test Kit(Time-Resolved FIA) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-FGIGE-302aW5 | 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 9c2307a6-cd49-4d86-a958-6d0d85be882e 61 fields · synced Jul 10, 2026