Identity

Trade Name
AQUAmed EUDAMED
Device Name
ECG GEL 1L EUDAMED
Model / Reference
AQUA15 EUDAMED

Identifiers

Primary DI / UDI-DI
08680525628280 EUDAMED
Basic UDI-DI
868052562AQ-019D EUDAMED
Direct Marketing DI
08680525628280 EUDAMED
EMDN Code
C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

AQUAmed by Aqua Medi̇kal Tibbi̇ Araç Ve Gereç İnş. San. Diş Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
TR-MF-000023642

Sources (1)

  • EUDAMED 2eaaf3e7-cab5-4c1f-a518-729ad13e60b6 61 fields · synced Jun 18, 2026