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Sharay Specific IgE Component Magnetic Beads (M) and Conjugate (R2)
EUDAMEDClass A (EU MDR)
Ref 14001059Model 200 Tests/kit
Identity
- Trade Name
- Sharay Specific IgE Component Magnetic Beads (M) and Conjugate (R2) EUDAMED
- Device Name
- Sharay Specific IgE Magnetic Beads (M) and Conjugate (R2) EUDAMED
- Model / Reference
- 200 Tests/kit EUDAMED14001059 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06980070461762 EUDAMED
- Basic UDI-DI
- 697507076000340RX EUDAMED
- Direct Marketing DI
- 06980070461762 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Sharay Specific IgE Component Magnetic Beads (M) and Conjugate (R2) by C-Luminary Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697507076000340RX | Class A | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 95edfbb2-3cd9-4fc4-890a-a7d012ac9386 61 fields · synced Sep 30, 2026