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Solaris

EUDAMED

Class I (EU MDR)

Ref NC14031-1Model 1032Ref NC14030Ref NC14033Ref NC14031

by North Coast Medical Inc.

Identity

Trade Name
Solaris EUDAMED
Device Name
Solaris EUDAMED
Model / Reference
1032 EUDAMED
NC14031-1 EUDAMED
NC14030 EUDAMED
NC14033 EUDAMED
NC14031 EUDAMED

Identifiers

Primary DI / UDI-DI
00768627002714 EUDAMED
00768627140300 EUDAMED
00768627140331 EUDAMED
00768627140317 EUDAMED
Basic UDI-DI
0768627CSTACC-1032-QU EUDAMED
Direct Marketing DI
00768627002714 EUDAMED
00768627140300 EUDAMED
00768627140331 EUDAMED
00768627140317 EUDAMED
EMDN Code
M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland 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

Solaris by North Coast Medical, Inc. — 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

Manufacturer
North Coast Medical Inc.
EUDAMED SRN
US-MF-000009087
Authorised Representative
ICON (LR) Limited IE-AR-000006507

Sources (4)

  • EUDAMED 51dc6a08-7448-4422-9177-74a5bc7efc33 61 fields · synced Sep 17, 2026
  • EUDAMED c38d4275-2138-4e35-8f0b-4c84a8050da6 61 fields · synced May 16, 2026
  • EUDAMED c248b440-71cd-4610-a54d-c4f04a72c56b 61 fields · synced May 17, 2026
  • EUDAMED 15c79781-8f91-4cd1-80b0-ff1b10dfe80f 61 fields · synced May 19, 2026