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ISE Urine Calibrator

EUDAMED

Class IVD General (EU MDR)

Ref 3012079Model Level3: 1×5mLRef 3011989Model Level2: 1×5mLRef 3012148Model Level1: 1×5mLRef 3011950Model Level4: 1×5mL

by Dirui Industrial Co., Ltd

Identity

Trade Name
ISE Urine Calibrator EUDAMED
Device Name
ISE Urine Calibrator EUDAMED
Model / Reference
Level3: 1×5mL EUDAMED
3012079 EUDAMED
Level2: 1×5mL EUDAMED
3011989 EUDAMED
Level1: 1×5mL EUDAMED
3012148 EUDAMED
Level4: 1×5mL EUDAMED
3011950 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202247286 EUDAMED
06942202247279 EUDAMED
06942202247262 EUDAMED
06942202247293 EUDAMED
Basic UDI-DI
B-06942202247286 EUDAMED
B-06942202247279 EUDAMED
B-06942202247262 EUDAMED
B-06942202247293 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 Urine 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 (4)

  • EUDAMED 7216781b-80d7-4963-a93a-46e0691711a5 61 fields · synced Jul 24, 2026
  • EUDAMED effa90c7-f39f-4e16-91eb-e9daa119c4f0 61 fields · synced May 18, 2026
  • EUDAMED d094ba9a-884a-4761-af74-d1996f5dfdcd 61 fields · synced May 18, 2026
  • EUDAMED 1bbdc935-5e2f-475d-a492-598d754b5d5c 61 fields · synced May 18, 2026