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Manual Wheelchair

EUDAMED

Class I (EU MDR)

Ref SYIV100-KZ-001Model SYIV100-HTK-001 SYIV100-HTK-002 SYIV100-HTK-003 SYIV100-HTK-004 SYIV100-HTK-005 SYIV100-HTK-006 SYIV100-HTK-007 SYIV100-HTK-008 SYIV100-HTK-009 SYIV100-HTK-010 SYIV100-HTK-011 SYIV100-HTK-012 SYIV100-HTK-013 SYIV100-HTK-014 SYIV100-CSD-001 SYIV100-CSD-002

by Tianjin Hongyue Medical Equipment Co., LTD

Identity

Trade Name
Manual Wheelchair EUDAMED
Device Name
Manual Wheelchair EUDAMED
Model / Reference
SYIV100-HTK-001 SYIV100-HTK-002 SYIV100-HTK-003 SYIV100-HTK-004 SYIV100-HTK-005 SYIV100-HTK-006 SYIV100-HTK-007 SYIV100-HTK-008 SYIV100-HTK-009 SYIV100-HTK-010 SYIV100-HTK-011 SYIV100-HTK-012 SYIV100-HTK-013 SYIV100-HTK-014 SYIV100-CSD-001 SYIV100-CSD-002 EUDAMED
SYIV100-KZ-001 EUDAMED

Identifiers

Primary DI / UDI-DI
06980055720181 EUDAMED
Basic UDI-DI
698005572MNWS9 EUDAMED
EMDN Code
Y122103 PUSH WHEELCHAIRS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Manual Wheelchair by Tianjin Hongyue Medical Equipment 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

EUDAMED SRN
CN-MF-000053849
Authorised Representative
HyperCert Limited B.V. NL-AR-000047746

Sources (1)

  • EUDAMED 08300f4e-8241-4800-bdf0-9ffb5d40e29d 61 fields · synced Jun 18, 2026