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McDavid

EUDAMED

Class I (EU MDR)

Ref X607R-BK-MModel X607R

by United Sports Brands

Identity

Trade Name
McDavid EUDAMED
Device Name
McDavid X Dual Layer Compression Elbow Sleeves EUDAMED
Model / Reference
X607R EUDAMED
X607R-BK-M EUDAMED

Identifiers

Primary DI / UDI-DI
00029369143470 EUDAMED
Basic UDI-DI
00029369X607R5F EUDAMED
EMDN Code
Y060615 ELBOW ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium 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

McDavid by United Sports Brands — 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
US-MF-000008428
Authorised Representative
QNET B.V. NL-AR-000002695

Sources (1)

  • EUDAMED 8bd0fbeb-b1db-46d7-ad56-dc568f919c3d 61 fields · synced Jun 17, 2026