← Back to catalogue
Sharay IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 14000398Model Model 1: IgG1Ref 14000401Model Model 4: IgG4Ref 14000399Model Model 2: IgG2Ref 14000400Model Model 3: IgG3Ref 14000837Model Model 2:IgG2Ref 14000839Model Model 4:IgG4Ref 14000836Model Model 1:IgG1
Identity
- Trade Name
- Sharay IgG (CLIA) EUDAMED
- Device Name
- Sharay IgG (CLIA) EUDAMED
- Model / Reference
- Model 1: IgG1 EUDAMED14000398 EUDAMEDModel 4: IgG4 EUDAMED14000401 EUDAMEDModel 2: IgG2 EUDAMED14000399 EUDAMEDModel 3: IgG3 EUDAMED14000400 EUDAMEDModel 2:IgG2 EUDAMED14000837 EUDAMEDModel 4:IgG4 EUDAMED14000839 EUDAMEDModel 1:IgG1 EUDAMED14000836 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070766115 EUDAMED06975070766146 EUDAMED06975070766122 EUDAMED06975070766139 EUDAMED06975070768850 EUDAMED06975070768874 EUDAMED06975070768843 EUDAMED
- Basic UDI-DI
- B-06975070766115 EUDAMEDB-06975070766146 EUDAMEDB-06975070766122 EUDAMEDB-06975070766139 EUDAMEDB-06975070768850 EUDAMEDB-06975070768874 EUDAMEDB-06975070768843 EUDAMED
- EMDN Code
- W0102010106 IMMUNOGLOBULIN G SUBCLASS REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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 IgG (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-06975070766115 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (7)
- EUDAMED ceeedf0f-02d1-444d-a2f5-0b377f7fd28b 61 fields · synced Aug 3, 2026
- EUDAMED 10febae3-fd43-4d52-b1f7-1d2f8e55e3d4 61 fields · synced May 17, 2026
- EUDAMED 64365e5e-4040-43e2-9f4b-3acf9a5486e6 61 fields · synced May 18, 2026
- EUDAMED 878a116e-e4d1-46d1-8dd6-d8bf0b71371a 61 fields · synced May 19, 2026
- EUDAMED 2960fba8-afa9-42ea-99b1-9e60dc6155bd 61 fields · synced Jun 20, 2026
- EUDAMED 73e2b2a2-5865-4065-92ff-aaa830626bea 61 fields · synced Jul 9, 2026
- EUDAMED a4860690-62e6-4516-b8d1-f934f035efa4 61 fields · synced Jul 11, 2026