Identity
- Trade Name
- TRIGLYCERIDES EUDAMED
- Device Name
- TRIGLYCERIDES EUDAMED
- Model / Reference
- 1417-0067 EUDAMED1418-0067 EUDAMED1516-0060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309136704 EUDAMED05204309039814 EUDAMED05204309175277 EUDAMED
- Basic UDI-DI
- 5204309000044NW EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
Category: Triglyceride IVD, reagent
Triglycerides by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 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 | 5204309000044NW | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (3)
- EUDAMED 23701c4f-0bb2-4f83-8a09-21523fe9ccc1 61 fields · synced Sep 18, 2026
- EUDAMED 3728a1da-197e-4905-bcbb-a6d3dbcd1170 61 fields · synced May 18, 2026
- EUDAMED 383606c3-d6b3-46c9-895b-b5601ca56260 61 fields · synced Jul 18, 2026