← Back to catalogue
Carbon Dioxide Reagent Kit(enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3001699Model R:2x50mL, Calibration sample: 1mLRef 3023561Model R:1x50mL, Calibration sample: 1mLRef 3019461Model R:2L, Calibration sample: 40mLRef 3021162Ref 3016517
Identity
- Trade Name
- CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD) EUDAMED
- Device Name
- CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD) EUDAMED
- Model / Reference
- R:2x50mL, Calibration sample: 1mL EUDAMED3001699 EUDAMEDR:1x50mL, Calibration sample: 1mL EUDAMED3023561 EUDAMEDR:2L, Calibration sample: 40mL EUDAMED3019461 EUDAMED3021162 EUDAMED3016517 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260285 EUDAMED06942202215742 EUDAMED06925794581310 EUDAMED06942202260254 EUDAMED06942202260261 EUDAMED
- Basic UDI-DI
- B-06942202260285 EUDAMEDB-06942202215742 EUDAMEDB-06925794581310 EUDAMEDB-06942202260254 EUDAMEDB-06942202260261 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
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
Carbon Dioxide Reagent Kit(enzymatic 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-06942202260285 | 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 (5)
- EUDAMED 377c78df-7e4f-42df-925e-36bb5b4f06e5 61 fields · synced Aug 2, 2026
- EUDAMED ff8537a1-c92f-4309-80f7-8529ca1f3f07 61 fields · synced Jul 18, 2026
- EUDAMED a78e5369-9f2a-4ec5-aeec-a0d8fd0f5b11 61 fields · synced Jul 18, 2026
- EUDAMED 1d21ffd8-bb12-45e5-9fc6-455f48a08678 61 fields · synced Jul 25, 2026
- EUDAMED de503104-ee6b-494a-af25-25c899828fcb 61 fields · synced Aug 2, 2026