← Back to catalogue
Anti Streptolysin-O Test Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Anti Streptolysin-O Test Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-11E7L EUDAMED
- Basic UDI-DI
- B-11E7L EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Anti Streptolysin-O Test Kit (Latex Immunoturbidimetric Method) by Shanghai Kehua Bio-engineering 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-11E7L | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Kehua Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026756
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 49fa13e7-8aca-4b75-96dd-fa3a736b3abe 61 fields · synced Jul 17, 2026