Identity
- Device Name
- PCT/IL-6 Rapid Detect EUDAMEDIL-6 Rapid Detect EUDAMED
- Model / Reference
- 808163 EUDAMED808160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-808163QL EUDAMEDD-808160QE EUDAMED
- Basic UDI-DI
- B-808163QL EUDAMEDB-808160QE EUDAMED
- EMDN Code
- W0102160699 RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
PCT/IL-6 Rapid Detect by Shenzhen Kang Sheng Bao Bio-Technology 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-808163QL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024153
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED d904e2e9-29a0-4033-a91d-5dfff562319b 61 fields · synced Oct 6, 2026
- EUDAMED 0e987733-ff38-4827-b4a4-a276d8df4ddc 61 fields · synced May 19, 2026