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Immunoglobulin M Kit（immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3012519Model R1: 1x50mL, R2: 1x10mLRef 3000956Ref 3023557Model R1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, Ref 3021194
Identity
- Trade Name
- IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 1x50mL, R2: 1x10mL EUDAMED3012519 EUDAMED3000956 EUDAMEDR1: 1x50mL, R2: 1x10mL, Calibration sample: 1x1mL, EUDAMED3023557 EUDAMED3021194 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260230 EUDAMED06942202246852 EUDAMED06942202216039 EUDAMED06942202260223 EUDAMED
- Basic UDI-DI
- B-06942202260230 EUDAMEDB-06942202246852 EUDAMEDB-06942202216039 EUDAMEDB-06942202260223 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
Immunoglobulin M Kit（immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202260230 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED bd64c689-c351-49ca-b9bd-d5c2a3699fc7 61 fields · synced Aug 2, 2026
- EUDAMED 38430135-6602-4cce-ac7c-614414cf9cd7 61 fields · synced May 18, 2026
- EUDAMED 64d5b255-4c19-4b6b-94a8-f1054498a55e 61 fields · synced Jun 18, 2026
- EUDAMED eb9a6e62-21b2-46b1-bcf5-ad5200445856 61 fields · synced Aug 2, 2026