← Back to catalogue
Interleukin-6 FIA Test (Whole blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref 6IL-4012F
Identity
- Trade Name
- Interleukin-6 FIA Test (Whole blood/Serum/Plasma) EUDAMED
- Device Name
- Interleukin-6 FIA Test (Whole blood/Serum/Plasma) EUDAMED
- Model / Reference
- 6IL-4012F EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6974246466IL000FCRTW EUDAMED
- Basic UDI-DI
- B-6974246466IL000FCRTW EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
- Models / Variants
- Whole blood EUDAMEDSerum EUDAMEDPlasma 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
Interleukin-6 FIA Test (Whole blood +2 more) by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models
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-6974246466IL000FCRTW | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- UnicareQ GmbH DE-AR-000051497
Sources (1)
- EUDAMED e65e26f9-b613-44d3-be26-b65062922ad6 61 fields · synced Jun 19, 2026