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Shoulder Immobilizer

EUDAMED

Class I (EU MDR)

Ref 210008(Universal/UNI/Black)Model Arm ABD Immobilizer:213106 Arm ABD Immobilizer:213107 Arm ABD Immobilizer:213108 Humeral Fracture Brace:210005 Mesh Sling:210001 Pillow Arm ABD Immobilizer:213103 Shoulder Abduction Immobilizer:213101 etc

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Shoulder Immobilizer EUDAMED
Device Name
Shoulder Sling (Shoulder immobilizer/orthosis and shoulder strap orthosis) EUDAMED
Model / Reference
Arm ABD Immobilizer:213106 Arm ABD Immobilizer:213107 Arm ABD Immobilizer:213108 Humeral Fracture Brace:210005 Mesh Sling:210001 Pillow Arm ABD Immobilizer:213103 Shoulder Abduction Immobilizer:213101 etc EUDAMED
210008(Universal/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872868873 EUDAMED
Basic UDI-DI
47198728621W8 EUDAMED
EMDN Code
Y060621 SHOULDER ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece 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

Shoulder Immobilizer by Zhangpu Ortholife 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
Zhangpu Ortholife Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED d1b70343-487e-4efe-a641-eb8b3822704a 61 fields · synced Oct 6, 2026