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Triglycerides Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref TG6011Y, TG6012Y, TG6013Y, TG6014Y, TG6015Y, TG6011N, TG6012N, TG6013N, TG6014N, TG6015N
Identity
- Trade Name
- Triglycerides Reagent Kit EUDAMED
- Device Name
- Triglycerides Reagent Kit EUDAMED
- Model / Reference
- TG6011Y, TG6012Y, TG6013Y, TG6014Y, TG6015Y, TG6011N, TG6012N, TG6013N, TG6014N, TG6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TG601X9 EUDAMED
- Basic UDI-DI
- B-TG601X9 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
Yes
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 Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 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 (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-TG601X9 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 386e5795-99c8-4c67-902b-7c78134805c1 61 fields · synced Jun 19, 2026
- EUDAMED 386e5795-99c8-4c67-902b-7c78134805c1-1 61 fields · synced Jun 9, 2026