Identity
- Device Name
- Triglycerides Reagent Kit (Enzymatic Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740740821 EUDAMED06935740739382 EUDAMED06935740733410 EUDAMED
- Basic UDI-DI
- 69357407ICAS000018AZ EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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 Reagent Kit (Enzymatic Method) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Triglyceride IVD, reagent.
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- JAS Diagnostics — Drew Scientific , Ltd. · Class I
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- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- 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 | 69357407ICAS000018AZ | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED c7efd8bd-db6e-49af-8f49-d327344c5cb9 61 fields · synced Jul 21, 2026
- EUDAMED a4fdaea3-12c8-417a-b926-e18123743e32 61 fields · synced May 18, 2026
- EUDAMED 07fcdfdf-27fa-49ec-8f9a-f5bd3b09868f 61 fields · synced May 19, 2026