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Immunoglobulin M Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090504Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH090510Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH090501Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH090507Model R1: 40 mL×4; R2: 10 mL×4
Identity
- Device Name
- Immunoglobulin M Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH090504 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090510 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH090501 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH090507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225462398 EUDAMED06975225462466 EUDAMED06975225462459 EUDAMED06975225462428 EUDAMED
- Basic UDI-DI
- B-06975225462398 EUDAMEDB-06975225462466 EUDAMEDB-06975225462459 EUDAMEDB-06975225462428 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Assay Kit (Immunoturbidimetric Method) by Da Te Bioengineering Technology 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-06975225462398 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 24296782-3c46-422b-bbbd-e4620f3ce17a 61 fields · synced Jul 11, 2026
- EUDAMED 6714e9c3-b90d-48e8-90f7-82c24d4a0993 61 fields · synced May 16, 2026
- EUDAMED 3a88fae1-a00d-4951-9173-5c3b2ba22072 61 fields · synced May 17, 2026
- EUDAMED 9949e616-ff68-48bb-8167-4b19868b4ae2 61 fields · synced May 18, 2026