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Total IgE Antibody Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref MY-0019-01Model Control 1: 1×0.5mL;Control 2: 1×0.5mL
Identity
- Trade Name
- Total IgE Antibody Quality Control EUDAMED
- Device Name
- Total IgE Antibody Quality Control EUDAMED
- Model / Reference
- Control 1: 1×0.5mL;Control 2: 1×0.5mL EUDAMEDMY-0019-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454910 EUDAMED
- Basic UDI-DI
- B-06976117454910 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Total IgE Antibody Quality Control by Shenzhen Dymind Biotechnology 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-06976117454910 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED b04e7b0d-5d50-4a78-bd82-60abfa39a475 61 fields · synced Jul 12, 2026