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SIMPLE Knee Immobilizer K4

EUDAMED

Class I (EU MDR)

Ref 110228-SModel 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)),

by Simple Medical (Shenzhen) Limited

Identity

Trade Name
SIMPLE Knee Immobilizer K4 EUDAMED
Device Name
SIMPLE Dual Upright Knee Brace H1，SIMPLE OA Knee Brace X1，SIMPLE Premium OA Knee Brace S2，SIMPLE Dual Upright Knee Brace H2，SIMPLE Premium Post-Op Knee Brace K1，SIMPLE Knee Immobilizer K3，SIMPLE Post-Op Knee Brace K2，， EUDAMED
Model / Reference
11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)), EUDAMED
110228-S EUDAMED

Identifiers

Primary DI / UDI-DI
06971244542967 EUDAMED
Basic UDI-DI
697124454KneeOrthosesED EUDAMED
Direct Marketing DI
06971244542967 EUDAMED
EMDN Code
Y061209 KNEE ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland 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

SIMPLE Knee Immobilizer K4 by Simple Medical (Shenzhen) Limited — 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
Simple Medical (Shenzhen) Limited
EUDAMED SRN
CN-MF-000013198
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 6b631c82-4c37-48e1-870d-6c7ca85a91cc 61 fields · synced Sep 18, 2026