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Post-op Elbow Brace

EUDAMED

Class I (EU MDR)

Ref 311001(Universal/Left/Black)Model Airform Elbow Strap:310004 Airform Elbow Strap:310006 Athena Elbow Support:312003 Elastic Elbow Support:312001 Elastic Elbow Support:312002 Elbow Strap:310003 Elbow Strap:318002 Elbow Strap With Pad:310002 etc

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Post-op Elbow Brace EUDAMED
Device Name
Elbow Brace, Post-OP Brace (Elbow orthosis) EUDAMED
Model / Reference
Airform Elbow Strap:310004 Airform Elbow Strap:310006 Athena Elbow Support:312003 Elastic Elbow Support:312001 Elastic Elbow Support:312002 Elbow Strap:310003 Elbow Strap:318002 Elbow Strap With Pad:310002 etc EUDAMED
311001(Universal/Left/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872862017 EUDAMED
Basic UDI-DI
47198728631WB EUDAMED
EMDN Code
Y060615 ELBOW 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

Post-op Elbow Brace 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 8c3e146f-4b4c-49e1-915e-0a3292340cd9 61 fields · synced Oct 6, 2026