← Back to catalogue
Immunoglobulin G Kit (Turbidimetry Method)
EUDAMEDClass B (EU MDR)
Ref 105-000883-00Model please see UDI-DI for detailsRef 105-001619-00
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 EUDAMED105-000883-00 EUDAMED105-001619-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904025391 EUDAMED06944904026398 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
Similar devices
Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- PRESTIGE 24i IgG — PZ CORMAY Spółka Akcyjna · IVD General
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Immunoglobulin G Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- IGG — Medicon Hellas SA · Class B
- A-400 IgG — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
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 (2)
- EUDAMED b67f8cf7-9890-48bb-a38e-36f9601129c6 61 fields · synced Oct 6, 2026
- EUDAMED 7a6df885-9b50-4499-b5af-730f948b9f2a 61 fields · synced May 18, 2026