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EchoStar 1.5T

EUDAMED

Class IIa (EU MDR)

Ref 017Model EchoStar 1.5T

by Alltech Medical Systems, LLC.

Identity

Trade Name: EchoStar 1.5T EUDAMED
Device Name: Magnetic resonance imaging EUDAMED
Model / Reference: EchoStar 1.5T EUDAMED
017 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974871790176 EUDAMED
Basic UDI-DI: B-06974871790176 EUDAMED
EMDN Code: Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Full-body MRI system, superconducting magnet

EchoStar 1.5T by Alltech Medical Systems, LLC. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Full-body MRI system, superconducting magnet.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Alltech Medical Systems, LLC.
EUDAMED SRN: CN-MF-000014724
Authorised Representative: Caretechion GmbH DE-AR-000005946

Sources (1)

EUDAMED a10be6c7-c559-4843-9350-54c4b53b6963 61 fields · synced Jun 20, 2026