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Orthoses, Upper Extremity

EUDAMED

Class I (EU MDR)

Ref TB-OS-32 SModel Orthopedic Supports -1Ref WR-OS-17 NeopreneRef TB-OS-32 RegularRef WR-OS-53 Left OLD

by Irufa Industrial Group CO., LTD.

Identity

Trade Name
ORTHOSES, UPPER EXTREMITY EUDAMED
Device Name
Ankle support/Wrist splint/knee support/thumb support EUDAMED
Model / Reference
Orthopedic Supports -1 EUDAMED
TB-OS-32 S EUDAMED
WR-OS-17 Neoprene EUDAMED
TB-OS-32 Regular EUDAMED
WR-OS-53 Left OLD EUDAMED

Identifiers

Primary DI / UDI-DI
00732240910442 EUDAMED
00732240910503 EUDAMED
00732240910237 EUDAMED
00732240910398 EUDAMED
Basic UDI-DI
007322409OLDERXY EUDAMED
EMDN Code
Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern 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

Orthoses, Upper Extremity by Irufa Industrial Group 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
Irufa Industrial Group CO., LTD.
EUDAMED SRN
TW-MF-000046083
Authorised Representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Sources (4)

  • EUDAMED 11356181-c810-42a1-bb97-350a3571b54f 61 fields · synced Oct 6, 2026
  • EUDAMED 4baced38-e8dc-445c-8e1a-a5ad7a68d678 61 fields · synced May 17, 2026
  • EUDAMED 537b0e0b-060c-4b05-b09c-f7193b04df61 61 fields · synced May 18, 2026
  • EUDAMED d2366223-c42e-4ba1-975b-9fc9635878b7 61 fields · synced May 19, 2026