← Back to catalogue
Bile Acid Reagent Kit（enzymatic Cycling Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3021738Model R1: 3x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3023562
Identity
- Trade Name
- BILE ACID REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
- Device Name
- BILE ACID REAGENT KIT（ENZYMATIC CYCLING METHOD） EUDAMED
- Model / Reference
- R1: 3x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3021738 EUDAMED3023562 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794593870 EUDAMED06942202215896 EUDAMED
- Basic UDI-DI
- B-06925794593870 EUDAMEDB-06942202215896 EUDAMED
- EMDN Code
- W01010202 BILE ACIDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Bile Acid Reagent Kit（enzymatic Cycling 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-06925794593870 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 37798216-9a40-4043-92e2-23a07ae256b1 61 fields · synced Jul 10, 2026
- EUDAMED d2357216-aa4b-4a64-b612-5b25f7394c23 61 fields · synced May 18, 2026