← Back to catalogue
Human anti-salivary gland protein I antibody CLlA Kit (IgA)
EUDAMEDClass IVD General (EU MDR)
Ref CK-2486-100ARef CK-2486-050A
Identity
- Device Name
- Human anti-salivary gland protein I antibody CLlA Kit (IgA) EUDAMED
- Model / Reference
- CK-2486-100A EUDAMEDCK-2486-050A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CK-2486-100A8E EUDAMEDD-CK-2486-050A8Y EUDAMED
- Basic UDI-DI
- B-CK-2486-100A8E EUDAMEDB-CK-2486-050A8Y EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Human anti-salivary gland protein I antibody CLlA Kit (IgA) by Guangzhou Kangrun Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-CK-2486-100A8E | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 7bf6227c-3a9c-44f0-821e-35ad7b092aff 61 fields · synced Oct 6, 2026
- EUDAMED f8dd6042-49ea-4eb7-9cc3-d6cf15f6548d 61 fields · synced May 18, 2026