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Sharay Specific IgE Bos d (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 14000404Model Model 3: Bos d 6Ref 14000405Model Model 4: Bos d 8Ref 14000657Model CR
Identity
- Trade Name
- Sharay Specific IgE Bos d (CLIA) EUDAMED
- Device Name
- Sharay Specific IgE Bos d (CLIA) EUDAMED
- Model / Reference
- Model 3: Bos d 6 EUDAMED14000404 EUDAMEDModel 4: Bos d 8 EUDAMED14000405 EUDAMEDCR EUDAMED14000657 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070765552 EUDAMED06975070765569 EUDAMED06975070767709 EUDAMED
- Basic UDI-DI
- B-06975070765552 EUDAMEDB-06975070765569 EUDAMEDB-06975070767709 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 Specific IgE Bos d (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06975070765552 | 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 (3)
- EUDAMED db110d5b-8741-45b4-936d-639ecfd12bda 61 fields · synced Jul 25, 2026
- EUDAMED aa2ceb58-8910-4e31-b7c7-1f635a711b15 61 fields · synced May 19, 2026
- EUDAMED 9cd3ba5d-7bf7-4139-985f-d7bfe1acc05d 61 fields · synced Jul 17, 2026