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Lower limb brace

EUDAMED

Class I (EU MDR)

Ref FT-018 SModel BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc

by Dongguan Supercare Medical Products Co., Ltd

Identity

Device Name
Lower limb brace EUDAMED
Model / Reference
BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc EUDAMED
FT-018 S EUDAMED

Identifiers

Primary DI / UDI-DI
06972782391826 EUDAMED
Basic UDI-DI
697278239LowerlimbbraceGD EUDAMED
EMDN Code
Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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

Lower limb brace by Dongguan Supercare Medical Products 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
Dongguan Supercare Medical Products Co., Ltd
EUDAMED SRN
CN-MF-000028597
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 023dcc60-38e5-451e-8344-470c82da867f 61 fields · synced Oct 5, 2026