← Back to catalogue
Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay )
EUDAMEDClass IVD General (EU MDR)
Ref 3011515Model R1: 1x20mL, R2: 1x5mLRef 3021578
Identity
- Trade Name
- Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay ) EUDAMED
- Device Name
- Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay ) EUDAMED
- Model / Reference
- R1: 1x20mL, R2: 1x5mL EUDAMED3011515 EUDAMED3021578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246456 EUDAMED06925794592453 EUDAMED
- Basic UDI-DI
- B-06942202246456 EUDAMEDB-06925794592453 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - 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
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
Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay ) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202246456 | 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 0cdfce4c-7d05-4a02-92ca-ff6428fc2de8 61 fields · synced Jul 14, 2026
- EUDAMED 26baa7c9-f38a-40fd-90a8-374cd6e674fd 61 fields · synced May 19, 2026