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Immunoglobulin (IgA/IgG/IgM) Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref 2S001
Identity
- Device Name
- Immunoglobulin (IgA/IgG/IgM) Reagent Kit EUDAMED
- Model / Reference
- 2S001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-02B0028YX EUDAMED
- Basic UDI-DI
- B-02B0028YX EUDAMED
- EMDN Code
- W0102010101,W0102010105,W0102010107 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Immunoglobulin (IgA/IgG/IgM) Reagent Kit by Changsha Sinocare Inc. — 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-02B0028YX | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2ded3a60-e488-4dfb-a907-3c29caf67093 61 fields · synced Jul 11, 2026