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Molded Body Jacket

EUDAMED

Class I (EU MDR)

Ref 240001(M/UNI/Gray&Silver)Ref 240001(XL/UNI/Gray&Silver)Ref 240001(L/UNI/Gray&Silver)Ref 240001(S/UNI/Gray&Silver)

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
Molded Body Jacket EUDAMED
Device Name
Back Brace (Thoracolumbar Support) EUDAMED
Model / Reference
240001(M/UNI/Gray&Silver) EUDAMED
240001(XL/UNI/Gray&Silver) EUDAMED
240001(L/UNI/Gray&Silver) EUDAMED
240001(S/UNI/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892936040 EUDAMED
04719892936064 EUDAMED
04719892936033 EUDAMED
04719892936057 EUDAMED
Basic UDI-DI
47199644624WC EUDAMED
EMDN Code
Y060306 THORACOLUMBAR ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Molded Body Jacket 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 (4)

  • EUDAMED 0ea275dc-111e-4909-b763-c9e41790aa82 61 fields · synced Oct 6, 2026
  • EUDAMED 333df436-f4bb-4202-8662-9281dcdd1531 61 fields · synced May 17, 2026
  • EUDAMED 1af58391-8bd3-44e2-9f1c-75aa6075077e 61 fields · synced May 17, 2026
  • EUDAMED 88f944ca-9e06-422e-9587-fa148538f14d 61 fields · synced May 18, 2026