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ISE blood sample calibrator

EUDAMED

Class IVD General (EU MDR)

Ref 3001254Model 5×4mLRef 3024567Model Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottleRef 3025267Model Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle

by Dirui Industrial Co., Ltd

Identity

Trade Name
ISE blood sample calibrator EUDAMED
Device Name
ISE blood sample calibrator EUDAMED
Model / Reference
5×4mL EUDAMED
3001254 EUDAMED
Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle EUDAMED
3024567 EUDAMED
Dissolved liquid: 4mL×5bottle，Freeze-dried powder: 0.18g×5bottle EUDAMED
3025267 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202261503 EUDAMED
06942202226502 EUDAMED
06942202230899 EUDAMED
Basic UDI-DI
B-06942202261503 EUDAMED
B-06942202226502 EUDAMED
B-06942202230899 EUDAMED
EMDN Code
W0101050301 CALIBRATORS MULTICOMPONENT (CC) 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 blood sample calibrator 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

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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 (3)

  • EUDAMED 4be8df5b-93cb-4273-98b2-362a7cede8ce 61 fields · synced Jul 10, 2026
  • EUDAMED 6b0ec672-14ad-418f-a781-44442a063f89 61 fields · synced Jun 20, 2026
  • EUDAMED 20ba61c4-fcc8-457e-ac2c-fd1b8e8f95a9 61 fields · synced Jul 10, 2026