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Simple Lo 103

EUDAMED

Class I (EU MDR)

Ref 52013-MModel 51001,51002,51007,51301,51302,51304,51320,51325,52001,52002,52003,52006,52008,52009,52013,52024,52025,52026

by Simple Medical (Shenzhen) Limited

Identity

Trade Name
SIMPLE LO 103 EUDAMED
Device Name
SIMPLE Cervical Collar C2, SIMPLE Cervical Collar C1, VertiComfort Collar 172, SIMPLE TLSO 301, VertiComfort TLSO464 , VertiComfort TLSO 456, SIMPLE Cryo TLSO 456, SIMPLE Cryo TLSO 464, VertiComfort LSO 625, SIMPLE LO105, VertiComfort LSO 631 EUDAMED
Model / Reference
51001,51002,51007,51301,51302,51304,51320,51325,52001,52002,52003,52006,52008,52009,52013,52024,52025,52026 EUDAMED
52013-M EUDAMED

Identifiers

Primary DI / UDI-DI
06971244542394 EUDAMED
Basic UDI-DI
697124454SpineOrthoses7Y EUDAMED
Direct Marketing DI
06971244542394 EUDAMED
EMDN Code
Y060308 LUMBOSACRAL SPINE 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 Lo 103 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 caba3b81-190f-4efc-892d-4199217ef7c0 61 fields · synced Jul 27, 2026