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Sharay Bullous Dermatosis IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18192001 Model Model 1: Sharay Anti-Bmz IgG, 100 Tests/kitRef 14000414Model Model 4: BP180Ref 18197001 Model Model: Sharay Anti-BP230 IgG, 100 Tests/kitRef 14000415Model Model 5: BP230Ref 18195001 Model Model: Sharay Anti-Dsg1 IgG, 100 Tests/kitRef 18196001 Model Model: Sharay Anti-BP180 IgG, 100 Tests/kitRef 14000412Model Model 2: Dsg1Model Model : Sharay Anti-Dsg3 IgG, 100 Tests/kitRef 14000688Ref 14000685
Identity
- Trade Name
- Sharay Bullous Dermatosis IgG (CLIA) EUDAMED
- Device Name
- Sharay Bullous Dermatosis IgG (CLIA) EUDAMED
- Model / Reference
- Model 1: Sharay Anti-Bmz IgG, 100 Tests/kit EUDAMED18192001 EUDAMEDModel 4: BP180 EUDAMED14000414 EUDAMEDModel: Sharay Anti-BP230 IgG, 100 Tests/kit EUDAMED18197001 EUDAMEDModel 5: BP230 EUDAMED14000415 EUDAMEDModel: Sharay Anti-Dsg1 IgG, 100 Tests/kit EUDAMED18195001 EUDAMEDModel: Sharay Anti-BP180 IgG, 100 Tests/kit EUDAMED18196001 EUDAMEDModel 2: Dsg1 EUDAMED14000412 EUDAMEDModel : Sharay Anti-Dsg3 IgG, 100 Tests/kit EUDAMED14000688 EUDAMED14000685 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762070 EUDAMED06975070766245 EUDAMED06975070762124 EUDAMED06975070766252 EUDAMED06975070762094 EUDAMED06975070762117 EUDAMED06975070766221 EUDAMED06975070762100 EUDAMED06975070768010 EUDAMED06975070767983 EUDAMED
- Basic UDI-DI
- B-06975070762070 EUDAMEDB-06975070766245 EUDAMEDB-06975070762124 EUDAMEDB-06975070766252 EUDAMEDB-06975070762094 EUDAMEDB-06975070762117 EUDAMEDB-06975070766221 EUDAMEDB-06975070762100 EUDAMEDB-06975070768010 EUDAMEDB-06975070767983 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMEDW0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER 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
No
EUDAMEDEUDAMED
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 Bullous Dermatosis 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-06975070762070 | 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 (12)
- EUDAMED 9ff4fac2-c407-4061-98ce-4b8e2053f789 61 fields · synced Aug 1, 2026
- EUDAMED c832ff9b-2afc-484d-8ddb-52a3e8ae69f3 61 fields · synced May 17, 2026
- EUDAMED 621188c7-5f01-4788-aab8-e410a5f9cd65 61 fields · synced May 17, 2026
- EUDAMED 95fb6be8-eefe-4d03-830d-f4ea29df1bea 61 fields · synced May 17, 2026
- EUDAMED 210f107f-9056-4ff7-8eff-5995539ac71c 61 fields · synced May 17, 2026
- EUDAMED ff991b7b-1822-4d9f-bdde-5110bc0b96bb 61 fields · synced May 18, 2026
- EUDAMED 60c5367d-3d70-46cc-9a1f-26043c7b61e1 61 fields · synced May 19, 2026
- EUDAMED ff9f0c81-3e7c-4494-b335-f94e7ba6663b 61 fields · synced May 19, 2026
- EUDAMED 512e19d8-5431-480c-8807-293dc58fcd21 61 fields · synced Jul 10, 2026
- EUDAMED 271e5a39-8f66-4ac1-95f9-5043f9e2130e 61 fields · synced Jul 13, 2026
- EUDAMED a59309b1-4849-49c3-9479-7ddcc8902202 61 fields · synced Jul 18, 2026
- EUDAMED e66ec64d-9854-44e1-a4b8-d082cdfb25ff 61 fields · synced Aug 1, 2026