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Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3011486Model R1：1x20mL, R2：1x5mL, R3：1x30mL,Glycated albumin calibration sample：1×1mL, Albumin calibration sample：1×1mLRef 3013045Model R1:R1：1×20mL，R2：1×5mL，R3：1×30mL,Glycated albumin control: 2x1mLRef 3021740Model R1：1×20mL，R2：1×5mL，R3：1×30mL,Glycated albumin calibration sample：1×1mL, Albumin calibration sample：1×1mL, Glycated albumin control: 2x1mL
Identity
- Trade Name
- Glycated Albumin Reagent Kit (Ketamine Oxidase Assay) EUDAMED
- Device Name
- Glycated Albumin Reagent Kit (Ketamine Oxidase Assay) EUDAMED
- Model / Reference
- R1：1x20mL, R2：1x5mL, R3：1x30mL,Glycated albumin calibration sample：1×1mL, Albumin calibration sample：1×1mL EUDAMED3011486 EUDAMEDR1:R1：1×20mL，R2：1×5mL，R3：1×30mL,Glycated albumin control: 2x1mL EUDAMED3013045 EUDAMEDR1：1×20mL，R2：1×5mL，R3：1×30mL,Glycated albumin calibration sample：1×1mL, Albumin calibration sample：1×1mL, Glycated albumin control: 2x1mL EUDAMED3021740 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246708 EUDAMED06942202239649 EUDAMED06925794593245 EUDAMED
- Basic UDI-DI
- B-06942202246708 EUDAMEDB-06942202239649 EUDAMEDB-06925794593245 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER 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
Glycated Albumin Reagent Kit (Ketamine Oxidase Assay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202246708 | 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 (3)
- EUDAMED 201c6e36-8488-46dc-8e15-9a92794b57da 61 fields · synced Jul 11, 2026
- EUDAMED 872c9a44-3c43-4975-bfae-e71c636c14e7 61 fields · synced Jul 11, 2026
- EUDAMED d9890944-613c-4eae-b771-e258406190c2 61 fields · synced Jul 11, 2026