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ISE standard solution
EUDAMEDClass IVD General (EU MDR)
Ref 3001220Model High: 3×10mLRef 3001221Model Low：3×10mLRef 3025271Model High: 1×10mL/bottleRef 3025281Model High: 3×10mL/bottleRef 3024566Model Low: 1×10mL/bottleRef 3025279Ref 3024570
Identity
- Trade Name
- ISE standard solution EUDAMED
- Device Name
- ISE standard solution EUDAMED
- Model / Reference
- High: 3×10mL EUDAMED3001220 EUDAMEDLow：3×10mL EUDAMED3001221 EUDAMEDHigh: 1×10mL/bottle EUDAMED3025271 EUDAMEDHigh: 3×10mL/bottle EUDAMED3025281 EUDAMEDLow: 1×10mL/bottle EUDAMED3024566 EUDAMED3025279 EUDAMED3024570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261534 EUDAMED06942202261541 EUDAMED06942202230967 EUDAMED06942202230974 EUDAMED06942202226489 EUDAMED06942202230943 EUDAMED06942202226496 EUDAMED
- Basic UDI-DI
- B-06942202261534 EUDAMEDB-06942202261541 EUDAMEDB-06942202230967 EUDAMEDB-06942202230974 EUDAMEDB-06942202226489 EUDAMEDB-06942202230943 EUDAMEDB-06942202226496 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
Yes
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 standard 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-06942202261534 | 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 54a883ca-be20-4294-8139-d937f4a0224e 61 fields · synced Sep 18, 2026
- EUDAMED 70f8f6d1-7dd1-4652-867a-bc93e940fc38 61 fields · synced May 18, 2026
- EUDAMED 89233f8e-9a2a-43ff-bc69-6ba378f11bc9 61 fields · synced Jul 22, 2026
- EUDAMED c4c0127a-4774-4386-8ab5-58b05329696c 61 fields · synced Jul 24, 2026
- EUDAMED 3b69371c-e110-4f12-b8fe-e2f2129a1c80 61 fields · synced Aug 2, 2026
- EUDAMED 257791bf-e171-4576-93e7-4d737d0a48a1 61 fields · synced Aug 4, 2026
- EUDAMED e4cdf9e4-dd94-4ae1-bcbe-0c420d9e5ef2 61 fields · synced Sep 18, 2026