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Triglycerides Liquizyme GPO-PAP (Single Reagent)
EUDAMEDClass B (EU MDR)
Ref 314 002
Identity
- Trade Name
- Triglycerides Liquizyme GPO-PAP (Single Reagent) EUDAMED
- Device Name
- Triglycerides Liquizyme GPO-PAP (Single Reagent) EUDAMED
- Model / Reference
- 314 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G4583140028B EUDAMED
- Basic UDI-DI
- ++G458314MS EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
Category: Triglyceride IVD, reagent
Triglycerides Liquizyme GPO-PAP (Single Reagent) by Spectrum for Diagnostic Industries (Joint Stock Company) — Class B — IVDR — listed in EUDAMED
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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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | ++G458314MS | Class B | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7eddb54e-3b16-4129-a056-cc7cd8ee5aaa 61 fields · synced Jun 19, 2026