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Sharay Dust Mite Allergen Components sIgG4 (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 14000696Model Model 2: Der p1, Der p 2, Der p 10, Der p 23
Identity
- Trade Name
- Sharay Dust Mite Allergen Components sIgG4 (CLIA) EUDAMED
- Device Name
- Sharay Dust Mite Allergen Components sIgG4 (CLIA) EUDAMED
- Model / Reference
- Model 2: Der p1, Der p 2, Der p 10, Der p 23 EUDAMED14000696 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070768119 EUDAMED
- Basic UDI-DI
- B-06975070768119 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Sharay Dust Mite Allergen Components sIgG4 (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06975070768119 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED aad449ae-8085-4ca1-a900-372ed91b14b1 61 fields · synced Jun 19, 2026