← Back to catalogue
Immunoglobulin M Kit (Turbidimetry Method)
EUDAMEDClass B (EU MDR)
Ref 105-000843-00Model 105-000843-00、105-000882-00、105-004606-00
Identity
- Trade Name
- Immunoglobulin M Kit (Turbidimetry Method) EUDAMED
- Device Name
- Immunoglobulin M Kit (Turbidimetry Method) EUDAMED
- Model / Reference
- 105-000843-00、105-000882-00、105-004606-00 EUDAMED105-000843-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904024998 EUDAMED
- Basic UDI-DI
- 694490400044IGM********K5 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M 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
Immunoglobulin M Kit (Turbidimetry Method) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 694490400044IGM********K5 | 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 (1)
- EUDAMED 5b2d5e75-17f4-4e69-b99a-062b114ec73f 61 fields · synced Jun 18, 2026