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Electrode

EUDAMED

Class A (EU MDR)

Ref DD-62005Ref DD-62004Ref CD-476246Ref DD-62003

by Diamond Diagnostics Inc

Identity

Trade Name
Electrode EUDAMED
Device Name
Cl- Electrode UNITY EUDAMED
K+ Electode UNITY EUDAMED
pO2 Electrode EUDAMED
Na+ Electrode UNITY EUDAMED
Model / Reference
DD-62005 EUDAMED
DD-62004 EUDAMED
CD-476246 EUDAMED
DD-62003 EUDAMED

Identifiers

Primary DI / UDI-DI
00811403014729 EUDAMED
00811403014712 EUDAMED
00811403010554 EUDAMED
00811403014705 EUDAMED
Basic UDI-DI
081140301DD620058B EUDAMED
081140301DD6200489 EUDAMED
081140301CD4762469F EUDAMED
081140301DD6200387 EUDAMED
EMDN Code
W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Hungary EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Electrode by DIAMOND DIAGNOSTICS Inc — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
US-MF-000035435
Authorised Representative
Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351

Sources (4)

  • EUDAMED ab82052b-5799-47a7-8848-3e7005777aec 61 fields · synced Aug 1, 2026
  • EUDAMED 108f8200-a111-476a-8997-42305c3fb21a 61 fields · synced May 17, 2026
  • EUDAMED 51eaa3dd-786b-4d95-937d-a66835733f47 61 fields · synced May 17, 2026
  • EUDAMED 60c8fba2-002a-40b4-a6eb-d9d55ce38696 61 fields · synced May 18, 2026