Identity
- Device Name
- LH Rapid Test EUDAMED
- Model / Reference
- 808127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-808127QG EUDAMED
- Basic UDI-DI
- B-808127QG EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC 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
LH Rapid Test 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-808127QG | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024153
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED bc8dd7e7-3045-48d1-8f05-4906ff0e1711 61 fields · synced Jun 19, 2026