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Triglycerides Reagent Kit（oxidase Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000709Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mLRef 3000711Model R1: 4x50mL, R2: 2x25mL, Calibration sample: 2mLRef 3000707Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mLRef 3016523Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3021180Model R1: 4x50mL, R2: 5x25mL，Calibration sample: 2mLRef 3023207
Identity
- Trade Name
- TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD） EUDAMED
- Device Name
- TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD） EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000709 EUDAMEDR1: 4x50mL, R2: 2x25mL, Calibration sample: 2mL EUDAMED3000711 EUDAMEDR1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000707 EUDAMEDR1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3016523 EUDAMEDR1: 4x50mL, R2: 5x25mL，Calibration sample: 2mL EUDAMED3021180 EUDAMED3023207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261008 EUDAMED06942202257452 EUDAMED06942202261046 EUDAMED06942202261039 EUDAMED06942202261022 EUDAMED06942202213328 EUDAMED
- Basic UDI-DI
- B-06942202261008 EUDAMEDB-06942202257452 EUDAMEDB-06942202261046 EUDAMEDB-06942202261039 EUDAMEDB-06942202261022 EUDAMEDB-06942202213328 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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 Reagent Kit（oxidase Method） by Dirui Industrial 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-06942202261008 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (6)
- EUDAMED 97cdc687-4680-4e2e-b65e-d5918bef3f86 61 fields · synced Jul 29, 2026
- EUDAMED fda98180-2ec5-4b54-b2c7-e9b924e11b33 61 fields · synced May 17, 2026
- EUDAMED 2c4c8c95-6412-4e4d-a455-47c81f40c1ff 61 fields · synced May 18, 2026
- EUDAMED d1ebd15e-15b5-4af7-bc6b-f4de8dcec48a 61 fields · synced Jul 17, 2026
- EUDAMED 87c5011b-aae1-4943-abd5-39dfc70929e5 61 fields · synced Jul 19, 2026
- EUDAMED 76df29b0-6c2f-4f6b-ba58-9d0837a03998 61 fields · synced Jul 29, 2026