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Sharay Anti-IF IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18159001 Model 100 Tests/kitRef 18159002
Identity
- Trade Name
- Sharay Anti-IF IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-IF IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18159001 EUDAMED18159002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762216 EUDAMED06975070767723 EUDAMED
- Basic UDI-DI
- B-06975070762216 EUDAMEDB-06975070767723 EUDAMED
- EMDN Code
- W0102070199 ANEMIA - OTHER EUDAMEDW0102070205 INTRINSIC FACTOR (BLOCKING ANTIBODY) 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
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 Anti-IF 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-06975070762216 | 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 (2)
- EUDAMED a2c757ef-a609-4694-a1e5-cba173f84e08 61 fields · synced Jul 26, 2026
- EUDAMED 4fae04dc-ca2a-4c3f-b60e-ca8aa96e212c 61 fields · synced Jul 26, 2026