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Triglyceride (TG) Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.02.02.EC.01
by Zybio Inc.
Identity
- Device Name
- Triglyceride (TG) Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 01.09.02.02.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967203810 EUDAMED
- Basic UDI-DI
- B-06941967203810 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Triglyceride (TG) Kit (Enzymatic Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06941967203810 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a632b215-d4ea-4702-96f1-5f4cc1cfd345 61 fields · synced Jun 19, 2026