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Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method)
EUDAMEDClass IVD General (EU MDR)
Ref Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method)Model R1: 2×30 mL, R2: 1×10 mL
Identity
- Device Name
- Immunoglobulin M (IgM) Assay Kit (Immunonephelometric Method) EUDAMED
- Model / Reference
- R1: 2×30 mL, R2: 1×10 mL EUDAMEDImmunoglobulin M (IgM) Assay Kit (Immunonephelometric Method) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300568 EUDAMED
- Basic UDI-DI
- B-06937287300568 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
EUDAMED
Animal Tissues
No
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 (IgM) Assay Kit (Immunonephelometric Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — 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-06937287300568 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 04fbdd7d-0f94-44df-ad5c-d5888ad9acc6 61 fields · synced Jul 9, 2026