Identity
- Trade Name
- Triglycerides (Single Reagent) EUDAMED
- Device Name
- Triglycerides (Single Reagent) EUDAMED
- Model / Reference
- 314 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041036434 EUDAMED
- Basic UDI-DI
- B-62230041036434 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 (Single Reagent) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Triglyceride IVD, reagent.
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Triglycerides Kit (GPO-POD Method) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- ΤΡΙΓΛΥΚΕΡΙΔΙΑ LIQUID 8x45 ml (UR8210/PPC300N) — Biotechnological Applications Ltd · IVD General
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- TRIGLYCERIDES — Medicon Hellas SA · Class B
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-62230041036434 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED b12629a1-9fb3-4837-9b17-a3a0f881445e 61 fields · synced Jul 30, 2026