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Albumin Reagent Kit (bromcresol Green Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3000545Model R: 2x80mL,Calibration sample: 2mLRef 3016547Model R:5x50mL, Calibration sample: 2mLRef 3000546Model R: 4x50mL,Calibration sample: 2mLRef 3023087Ref 3019476Model R:1L, Calibration sample: 2mLRef 3021525Ref 3016518
Identity
- Trade Name
- ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD) EUDAMED
- Device Name
- ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD) EUDAMED
- Model / Reference
- R: 2x80mL,Calibration sample: 2mL EUDAMED3000545 EUDAMEDR:5x50mL, Calibration sample: 2mL EUDAMED3016547 EUDAMEDR: 4x50mL,Calibration sample: 2mL EUDAMED3000546 EUDAMED3023087 EUDAMEDR:1L, Calibration sample: 2mL EUDAMED3019476 EUDAMED3021525 EUDAMED3016518 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202258770 EUDAMED06942202258763 EUDAMED06942202258787 EUDAMED06942202211478 EUDAMED06925794581365 EUDAMED06925794592194 EUDAMED06942202258749 EUDAMED
- Basic UDI-DI
- B-06942202258770 EUDAMEDB-06942202258763 EUDAMEDB-06942202258787 EUDAMEDB-06942202211478 EUDAMEDB-06925794581365 EUDAMEDB-06925794592194 EUDAMEDB-06942202258749 EUDAMED
- EMDN Code
- W01010201 ALBUMIN (CC) 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
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
Albumin Reagent Kit (bromcresol Green 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-06942202258770 | 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 (7)
- EUDAMED 75885834-510f-4435-a9a3-1e43f220f32e 61 fields · synced Aug 1, 2026
- EUDAMED 0920e9fc-90ed-47ee-8c81-ddb28931ac73 61 fields · synced May 17, 2026
- EUDAMED e4e07b74-1e32-4812-a464-7220d745390e 61 fields · synced May 17, 2026
- EUDAMED bc63b4d6-fb2c-468f-a529-b901e2178867 61 fields · synced May 17, 2026
- EUDAMED 48f45c2d-dd2e-40b2-89dc-3ca005e205fe 61 fields · synced May 17, 2026
- EUDAMED 79912dc6-b547-45a9-b331-9f90b309ad1d 61 fields · synced May 18, 2026
- EUDAMED a866eda8-5552-46b2-9efa-22adeda87c82 61 fields · synced May 18, 2026