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Wedge Pillow

EUDAMED

Class I (EU MDR)

Ref 10EEKW

by Small Beginnings, Inc.

Identity

Trade Name
Wedge Pillow EUDAMED
Device Name
Positioning Device EUDAMED
Model / Reference
10EEKW EUDAMED

Identifiers

Primary DI / UDI-DI
00815090013270 EUDAMED
Basic UDI-DI
081509001POSITIONING5X EUDAMED
EMDN Code
V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Category: Assistive crawler/mobility board

Wedge Pillow by Small Beginnings, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Assistive crawler/mobility board.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000021428
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED 9fcab286-f2ce-48bd-8924-89721f7d050a 61 fields · synced Jun 19, 2026