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Sharay Birch Allergen Components sIgE (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 14000703Model Model 1: Bet v 1,Bet v 2,Bet v 4
Identity
- Trade Name
- Sharay Birch Allergen Components sIgE (CLIA) EUDAMED
- Device Name
- Sharay Birch Allergen Components sIgE (CLIA) EUDAMED
- Model / Reference
- Model 1: Bet v 1,Bet v 2,Bet v 4 EUDAMED14000703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070768188 EUDAMED
- Basic UDI-DI
- B-06975070768188 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
Sharay Birch Allergen Components sIgE (CLIA) by C-Luminary 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-06975070768188 | 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 f3beb718-f6d1-47fc-90bd-5995fbea507f 61 fields · synced Jul 22, 2026