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Allergen-Specific lgE Antibody Quality Control
EUDAMEDClass IVD General (EU MDR)
Ref MY-0031-01Model Specification 5,Control 1: 1×0.5 mL,Control 2: 1×0.5 mL
Identity
- Trade Name
- Allergen-Specific lgE Antibody Quality Control EUDAMED
- Device Name
- Allergen-Specific lgE Antibody Quality Control EUDAMED
- Model / Reference
- Specification 5,Control 1: 1×0.5 mL,Control 2: 1×0.5 mL EUDAMEDMY-0031-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454965 EUDAMED
- Basic UDI-DI
- B-06976117454965 EUDAMED
- EMDN Code
- W01020204 IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG 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
Allergen-Specific lgE Antibody Quality Control by Shenzhen Dymind Biotechnology 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-06976117454965 | 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 85ccdcf7-90e2-43aa-9a9e-45e7db895180 61 fields · synced Oct 6, 2026