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Handrails

EUDAMED

Class I (EU MDR)

Ref A-0290MRef A-0131E2Ref A-0163HRef A-0163GRef A-0290N

by Shih Kuo Enterprise Co., Ltd.

Identity

Device Name
Handrails EUDAMED
Model / Reference
A-0290M EUDAMED
A-0131E2 EUDAMED
A-0163H EUDAMED
A-0163G EUDAMED
A-0290N EUDAMED

Identifiers

Primary DI / UDI-DI
04712867056903 EUDAMED
04712867056316 EUDAMED
04712867056644 EUDAMED
04712867056637 EUDAMED
04712867056910 EUDAMED
Basic UDI-DI
471286705GB6HD EUDAMED
Direct Marketing DI
04712867056903 EUDAMED
04712867056316 EUDAMED
04712867056644 EUDAMED
04712867056637 EUDAMED
04712867056910 EUDAMED
EMDN Code
Y181803 HANDRAILS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED
Spain 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

Handrails by Shih Kuo Enterprise 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
Shih Kuo Enterprise Co., Ltd.
EUDAMED SRN
TW-MF-000012251
Authorised Representative
KOMAS Medical Technology GmbH DE-AR-000045617

Sources (5)

  • EUDAMED ffd61ffb-cc67-4274-a9b3-94e8305aff09 61 fields · synced Jul 22, 2026
  • EUDAMED fbdaa62a-a09d-4821-8ee3-9f0096046993 61 fields · synced May 16, 2026
  • EUDAMED f468d047-887d-457b-a49b-9556d0d09d33 61 fields · synced May 17, 2026
  • EUDAMED 9f5019e4-5dea-4b8e-a171-ea0fd1ed96eb 61 fields · synced May 17, 2026
  • EUDAMED 73eb884b-a30b-42bc-ba44-8c9590bb2668 61 fields · synced May 18, 2026