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Creatinine Reagent Kit（enzyme Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3016513Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mLRef 3021552Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3016564Ref 3000653Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mLRef 3000655Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL
Identity
- Trade Name
- CREATININE REAGENT KIT（ENZYME METHOD） EUDAMED
- Device Name
- CREATININE REAGENT KIT（ENZYME METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3016513 EUDAMEDR1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3021552 EUDAMED3016564 EUDAMEDR1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000653 EUDAMEDR1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259524 EUDAMED06925794592576 EUDAMED06942202259531 EUDAMED06942202259500 EUDAMED06942202259487 EUDAMED
- Basic UDI-DI
- B-06942202259524 EUDAMEDB-06925794592576 EUDAMEDB-06942202259531 EUDAMEDB-06942202259500 EUDAMEDB-06942202259487 EUDAMED
- EMDN Code
- W01010207 CREATININE EUDAMEDW01010232 URIC ACID 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
Creatinine Reagent Kit（enzyme Method） 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-06942202259524 | 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 (5)
- EUDAMED 7f0516f3-3784-48e7-90e0-60e0f9c129a1 61 fields · synced Sep 17, 2026
- EUDAMED d05a0148-18a2-4d28-909b-79ed10638545 61 fields · synced May 17, 2026
- EUDAMED a9204315-4bca-44ab-bca5-6b093322d2e2 61 fields · synced May 18, 2026
- EUDAMED bda87942-eb73-4ac1-8971-e9b41cb0b33d 61 fields · synced May 18, 2026
- EUDAMED d4854887-04b6-423d-aba5-ede4655ac3b5 61 fields · synced May 18, 2026