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Humeral Fracture Brace

EUDAMED

Class I (EU MDR)

Ref 210005(M/UNI/White)Model Mesh Sling:210001 TC Sling:210002 Universal Swathe Sling:210003 Shoulder Support:210004 Humeral Fracture Brace:210005 Shoulder Immobilizer:210008 Shoulder Abduction Immobilizer:213101 Pillow Arm ABD Immobilizer:213103 etc

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
Humeral Fracture Brace EUDAMED
Device Name
Shoulder Sling (Shoulder immobilizer/orthosis and shoulder strap orthosis) EUDAMED
Model / Reference
Mesh Sling:210001 TC Sling:210002 Universal Swathe Sling:210003 Shoulder Support:210004 Humeral Fracture Brace:210005 Shoulder Immobilizer:210008 Shoulder Abduction Immobilizer:213101 Pillow Arm ABD Immobilizer:213103 etc EUDAMED
210005(M/UNI/White) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892935500 EUDAMED
Basic UDI-DI
47199644621W6 EUDAMED
EMDN Code
Y060621 SHOULDER ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Humeral Fracture Brace by Orthotech Rehabilitation Co., Ltd. — 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
Orthotech Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000051924
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 77b1b867-79b6-472d-8565-7859226ff5fc 61 fields · synced Oct 6, 2026