← Back to catalogue
ISE Reference Solution
EUDAMEDClass IVD General (EU MDR)
Ref 3002410Model 1×2LRef 3001230Model 1×500mLRef 3013338Ref 3025856Model 2LRef 3025274Ref 3025841Model 500mLRef 3025284Ref 3024564
Identity
- Trade Name
- ISE Reference Solution EUDAMED
- Device Name
- ISE Reference Solution EUDAMED
- Model / Reference
- 1×2L EUDAMED3002410 EUDAMED1×500mL EUDAMED3001230 EUDAMED3013338 EUDAMED2L EUDAMED3025856 EUDAMED3025274 EUDAMED500mL EUDAMED3025841 EUDAMED3025284 EUDAMED3024564 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261480 EUDAMED06942202261466 EUDAMED06942202261497 EUDAMED06942202235573 EUDAMED06942202230837 EUDAMED06942202235610 EUDAMED06942202230868 EUDAMED06942202226458 EUDAMED
- Basic UDI-DI
- B-06942202261480 EUDAMEDB-06942202261466 EUDAMEDB-06942202261497 EUDAMEDB-06942202235573 EUDAMEDB-06942202230837 EUDAMEDB-06942202235610 EUDAMEDB-06942202230868 EUDAMEDB-06942202226458 EUDAMED
- EMDN Code
- W01010399 ELECTROLYTES - 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
ISE Reference Solution 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-06942202261480 | 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 (8)
- EUDAMED d518a125-f11f-4f57-a8ce-fedc27c281ac 61 fields · synced Aug 4, 2026
- EUDAMED 423160c2-4628-4053-9e90-bed4b53572d3 61 fields · synced May 18, 2026
- EUDAMED fa3271b2-bc6a-4850-a107-d0c8dcc2e53c 61 fields · synced May 19, 2026
- EUDAMED 51434b99-322f-4638-8135-c39c30d36af6 61 fields · synced Jul 9, 2026
- EUDAMED d59df196-f2dd-49aa-b8b2-17ae76620c97 61 fields · synced Jul 10, 2026
- EUDAMED 2d73398d-252f-47f3-b6a2-b319eed82193 61 fields · synced Jul 11, 2026
- EUDAMED 7c994c04-c458-45af-b8f4-fab9ec86ecf8 61 fields · synced Jul 13, 2026
- EUDAMED 431c9f09-eda6-4d7e-9b50-21274d01217d 61 fields · synced Jul 25, 2026