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Immunoglobulin G Kit (Turbidimetry Method)
EUDAMEDClass B (EU MDR)
Ref 105-004619-00Model please see UDI-DI for details
Identity
- Trade Name
- Immunoglobulin G Kit (Turbidimetry Method) EUDAMED
- Device Name
- Immunoglobulin G Kit (Turbidimetry Method) EUDAMED
- Model / Reference
- please see UDI-DI for details EUDAMED105-004619-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904053509 EUDAMED
- Basic UDI-DI
- 69449040AB71000023Z EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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
New Device
No
EUDAMED
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G Kit (Turbidimetry Method) by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class B — IVDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69449040AB71000023Z | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9551d179-06ec-47ce-972b-298d80639af5 61 fields · synced Oct 6, 2026