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Tennis Elbow Brace

EUDAMED

Class I (EU MDR)

Ref 310007(S/M/UNI/Black)Model Elbow Strap With Pad:310002 Elbow Strap:310003 Airform Elbow Strap:310004 Neoprene Elbow Sleeve:310005 Airform Elbow Strap:310006 Tennis Elbow Brace:310007 Tennis Elbow Air Brace:310008 etcRef 310007(L/XL/UNI/Black)

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
Tennis Elbow Brace EUDAMED
Device Name
Elbow Brace, Post-OP Brace (Elbow orthosis) EUDAMED
Model / Reference
Elbow Strap With Pad:310002 Elbow Strap:310003 Airform Elbow Strap:310004 Neoprene Elbow Sleeve:310005 Airform Elbow Strap:310006 Tennis Elbow Brace:310007 Tennis Elbow Air Brace:310008 etc EUDAMED
310007(S/M/UNI/Black) EUDAMED
310007(L/XL/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719964463733 EUDAMED
04719964463740 EUDAMED
Basic UDI-DI
47199644631W9 EUDAMED
EMDN Code
Y060615 ELBOW ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland 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

Tennis Elbow 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 (2)

  • EUDAMED 41f70844-eb82-4448-88ce-da6c578bb235 61 fields · synced Oct 6, 2026
  • EUDAMED 2b8b7645-0362-48fd-9dc4-82e9273bb332 61 fields · synced May 19, 2026