Lower Limbs Braces

by Dongguan Supercare Medical Products Co., Ltd 166 variants

Ref FT-002 MModel BK-055 BK-056 CF-002 CF-003 TH-001 KN-001 KN-003 KN-005 KN-026 FT-002 FT-006 FT-044 etc

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697892753LowerLimbBraceVD Basic UDI-DI 06978927533526UDI-DI	Date15 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Lower Limbs Braces
Model / Reference: BK-055 BK-056 CF-002 CF-003 TH-001 KN-001 KN-003 KN-005 KN-026 FT-002 FT-006 FT-044 etc, FT-002 M

Primary DI / UDI-DI: 06978927533526
Basic UDI-DI: 697892753LowerLimbBraceVD
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000028597
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Supercare Medical Products Co., Ltd

Wrist Supports

Class I
Lower Limbs Braces

Class I
Arm Slings

Class I
Lumbo-Sacral Back Brace

Class I
Clacivle Splint

Class I
Ankle Supports

Class I

See all devices from Dongguan Supercare Medical Products Co., Ltd →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No