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Calcium Reagent Kit (arsenazo Iii Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3000837Model R: 2x80mL,Calibration sample: 2mLRef 3000836Model R: 5x50ml,Calibration sample: 2mLRef 3000838Model R: 4x50mL,Calibration sample: 2mLRef 3021527Model R:5x50mL, Calibration sample: 2mLRef 3021200Ref 3017277Ref 3023211
Identity
- Trade Name
- CALCIUM REAGENT KIT (ARSENAZO III METHOD) EUDAMED
- Device Name
- CALCIUM REAGENT KIT (ARSENAZO III METHOD) EUDAMED
- Model / Reference
- R: 2x80mL,Calibration sample: 2mL EUDAMED3000837 EUDAMEDR: 5x50ml,Calibration sample: 2mL EUDAMED3000836 EUDAMEDR: 4x50mL,Calibration sample: 2mL EUDAMED3000838 EUDAMEDR:5x50mL, Calibration sample: 2mL EUDAMED3021527 EUDAMED3021200 EUDAMED3017277 EUDAMED3023211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261312 EUDAMED06942202246869 EUDAMED06942202260292 EUDAMED06925794592408 EUDAMED06942202260308 EUDAMED06942202260339 EUDAMED06942202213168 EUDAMED
- Basic UDI-DI
- B-06942202261312 EUDAMEDB-06942202246869 EUDAMEDB-06942202260292 EUDAMEDB-06925794592408 EUDAMEDB-06942202260308 EUDAMEDB-06942202260339 EUDAMEDB-06942202213168 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
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
Calcium Reagent Kit (arsenazo Iii 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-06942202261312 | 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 eeb14f07-f403-408a-b030-17d2f3956056 61 fields · synced Aug 4, 2026
- EUDAMED 231b105f-420a-414f-8d38-4b94a184d420 61 fields · synced May 16, 2026
- EUDAMED 3f32245d-bb9c-4625-b29b-de35cfa597f8 61 fields · synced May 18, 2026
- EUDAMED 946bffa3-7651-43fe-bc34-490748d2af81 61 fields · synced Jul 9, 2026
- EUDAMED b907fa07-67c6-45a5-a0b2-6325729544c9 61 fields · synced Jul 16, 2026
- EUDAMED 1b3816ea-6214-4d2a-bbcb-f15d6401073d 61 fields · synced Jul 25, 2026
- EUDAMED 27f9cf39-b618-4bca-976f-9225c124c455 61 fields · synced Aug 4, 2026