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Triglycerides (TG) Assay Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 98H200TSCRef 98H50TRef 98H50TSC
Identity
- Trade Name
- Triglycerides (TG) Assay Kit (Enzymatic Method) EUDAMED
- Device Name
- Triglycerides (TG) Assay Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 98H200TSC EUDAMED98H50T EUDAMED98H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-98H200TSCCV EUDAMEDD-98H50TZ4 EUDAMEDD-98H50TSCXU EUDAMED
- Basic UDI-DI
- B-98H200TSCCV EUDAMEDB-98H50TZ4 EUDAMEDB-98H50TSCXU EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Category: Triglyceride IVD, reagent
Triglycerides (TG) Assay Kit (Enzymatic Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Triglyceride IVD, reagent.
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
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- 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 (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-98H200TSCCV | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED 184ba68c-87e0-481d-b001-5cfb39ae51f6 61 fields · synced Jul 17, 2026
- EUDAMED 3a420029-a9e5-4a01-977a-672a0467ea7b 61 fields · synced May 17, 2026
- EUDAMED 2d89c35b-c0f1-4c39-a049-c7774cdc32c2 61 fields · synced May 17, 2026