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Upper Limb Brace

EUDAMED

Class I (EU MDR)

Ref S113Model BZ111 BZ112 BZ113 BZ114 BZ115 BZ116 BZ117 BZ118 BZ119 BZ120 BZ121 BZ122 BZ123 BZ124 BZ125 BZ126 BZ127 BZ128 BZ129 BZ130 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 UB001 UB002 etc

by Hengshui Jingkang Medical Device Co., Ltd

Identity

Device Name
Upper Limb Brace EUDAMED
Model / Reference
BZ111 BZ112 BZ113 BZ114 BZ115 BZ116 BZ117 BZ118 BZ119 BZ120 BZ121 BZ122 BZ123 BZ124 BZ125 BZ126 BZ127 BZ128 BZ129 BZ130 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 S129 S130 UB001 UB002 etc EUDAMED
S113 EUDAMED

Identifiers

Primary DI / UDI-DI
06974141900236 EUDAMED
Basic UDI-DI
697414190ULB001GP EUDAMED
Direct Marketing DI
06974141900236 EUDAMED
EMDN Code
Y060621 SHOULDER ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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

Upper Limb Brace by Hengshui Jingkang Medical Device 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-000041859
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 8a808a15-bdfa-42c0-8b95-6083773ff593 61 fields · synced Oct 6, 2026