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Sharay Specific IgE (Mixed Allergens 1) (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 14000346Model Model 2: Food mix 1Ref 14000869Model Model 1: Tree pollen Tx11Ref 14000706Model Model 1: Tree pollen Tx11, 100 Tests/KitRef 14000709Model Model 4: Weed pollen Wx7, 100 Tests/KitRef 14000873Model Model 5: Weed pollen Wx8Ref 14000711Model Model 6: Moulds Mx2, 100 Tests/KitRef 14000712Model Model 7: Nuts Fx50, 100 Tests/KitRef 14000708Model Model 3: Tree pollen Tx13, 100 Tests/KitRef 14000871Model Model 3: Tree pollen Tx13
Identity
- Trade Name
- Sharay Specific IgE (Mixed Allergens 1) (CLIA) EUDAMEDSharay Specific IgE (Mixed Allergens 2) (CLIA) EUDAMED
- Device Name
- Sharay Specific IgE (Mixed Allergens 1) (CLIA) EUDAMEDSharay Specific IgE (Mixed Allergens 2) (CLIA) EUDAMED
- Model / Reference
- Model 2: Food mix 1 EUDAMED14000346 EUDAMEDModel 1: Tree pollen Tx11 EUDAMED14000869 EUDAMEDModel 1: Tree pollen Tx11, 100 Tests/Kit EUDAMED14000706 EUDAMEDModel 4: Weed pollen Wx7, 100 Tests/Kit EUDAMED14000709 EUDAMEDModel 5: Weed pollen Wx8 EUDAMED14000873 EUDAMEDModel 6: Moulds Mx2, 100 Tests/Kit EUDAMED14000711 EUDAMEDModel 7: Nuts Fx50, 100 Tests/Kit EUDAMED14000712 EUDAMEDModel 3: Tree pollen Tx13, 100 Tests/Kit EUDAMED14000708 EUDAMEDModel 3: Tree pollen Tx13 EUDAMED14000871 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070765590 EUDAMED06975070769208 EUDAMED06975070768218 EUDAMED06975070768249 EUDAMED06975070769246 EUDAMED06975070768263 EUDAMED06975070768270 EUDAMED06975070768232 EUDAMED06975070769222 EUDAMED
- Basic UDI-DI
- B-06975070765590 EUDAMEDB-06975070769208 EUDAMEDB-06975070768218 EUDAMEDB-06975070768249 EUDAMEDB-06975070769246 EUDAMEDB-06975070768263 EUDAMEDB-06975070768270 EUDAMEDB-06975070768232 EUDAMEDB-06975070769222 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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 (Mixed Allergens 1) (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-06975070765590 | 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 (9)
- EUDAMED 2a5a59e8-4bfd-4ee6-a54e-7157af7322d3 61 fields · synced Jul 26, 2026
- EUDAMED 4c412227-82ba-4f78-9bce-c56be795ea3c 61 fields · synced Jun 14, 2026
- EUDAMED 80611620-99c1-486f-b67b-82d301a60c8e 61 fields · synced Jul 9, 2026
- EUDAMED 4540f6bc-1e96-46dd-b1ef-bc49d2ca8a38 61 fields · synced Jul 10, 2026
- EUDAMED b77da075-8e32-4c7b-9f57-51a28c871056 61 fields · synced Jul 10, 2026
- EUDAMED c1d5760e-3268-4897-beb5-a09fdea118de 61 fields · synced Jul 10, 2026
- EUDAMED b5965dec-6e27-474b-bc24-45486a4abc77 61 fields · synced Jul 22, 2026
- EUDAMED cf52d88a-cf9e-4779-9a07-052615bc98b6 61 fields · synced Jul 23, 2026
- EUDAMED 81d8197b-92cd-4f05-bd50-d89a85c0b2d6 61 fields · synced Jul 26, 2026