Identity
- Trade Name
- TRIGLYCERIDES SL EUDAMEDFDA UDI
- Generic Name
- Triglyceride IVD, kit, spectrophotometry FDA UDI
- Device Name
- TRIGLYCERIDES SL EUDAMED
- Model / Reference
- TGML-0250 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700826507 EUDAMEDFDA UDI
- Basic UDI-DI
- 37017008TGML00DC EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
- GMDN Term
- Triglyceride IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Triglyceride IVD, reagent
Triglycerides Sl by Vitalscientific — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Triglyceride IVD, reagent.
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008TGML00DC | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 1d1ff223-d8a4-40a4-9d95-02a32d3c4d2a 61 fields · synced Jul 10, 2026
- FDA UDI b62e209c-3b46-4120-b14f-78a3be2ddba7 32 fields · synced May 29, 2026