Identity
- Device Name
- Triglycerides Kit (GPO–PAP Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1466Z EUDAMED
- Basic UDI-DI
- B-1466Z EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Category: Triglyceride IVD, reagent
Triglycerides Kit (GPO–PAP Method) by Shanghai Kehua Bio-engineering Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Triglyceride IVD, reagent.
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- TRIGLYCERIDES — Medicon Hellas SA · Class B
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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-1466Z | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Kehua Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026756
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED dd2464ad-2bf7-444e-a9e1-1ef6b5647302 61 fields · synced Jun 17, 2026