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ISE Internal Standard Solution
EUDAMEDClass IVD General (EU MDR)
Ref 3013323Model 1×2LRef 3025270Model 2LRef 3025859Ref 3025283Ref 3021570
Identity
- Trade Name
- ISE Internal Standard Solution EUDAMED
- Device Name
- ISE Internal Standard Solution EUDAMED
- Model / Reference
- 1×2L EUDAMED3013323 EUDAMED2L EUDAMED3025270 EUDAMED3025859 EUDAMED3025283 EUDAMED3021570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261565 EUDAMED06942202230851 EUDAMED06942202235597 EUDAMED06942202230820 EUDAMED06925794594105 EUDAMED
- Basic UDI-DI
- B-06942202261565 EUDAMEDB-06942202230851 EUDAMEDB-06942202235597 EUDAMEDB-06942202230820 EUDAMEDB-06925794594105 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 Internal 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-06942202261565 | 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 (5)
- EUDAMED 7158df85-d33d-46c1-9b50-043300dc52e0 61 fields · synced Sep 18, 2026
- EUDAMED 6f51edf4-21c0-4a44-9731-db32ceaf6e91 61 fields · synced Jul 11, 2026
- EUDAMED 973b472f-9c00-42bd-a92e-3d4fb27242bd 61 fields · synced Jul 21, 2026
- EUDAMED 801f8514-a72d-4b94-acae-072a08825267 61 fields · synced Jul 30, 2026
- EUDAMED bc66b36d-9479-4e1a-a610-c298cb3d38b7 61 fields · synced Sep 18, 2026