Plantar Fasciitis Splint

by Guangdong New Design Biotechnology Co., Ltd 4 variants

Ref ZY1

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	Number697765270ZY1Z2 Basic UDI-DI 06977652700104UDI-DI	Date22 Apr 2025Registered	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Withdrawn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

Model / Reference: ZY1

Primary DI / UDI-DI: 06977652700104
Basic UDI-DI: 697765270ZY1Z2
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000043910
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Guangdong New Design Biotechnology Co., Ltd

Neck Brace

Class I
Bunion Corrector

Class I
Bunion Corrector

Class I
Bunion Corrector

Class I
Bunion Corrector

Class I
Neck Brace

Class I

See all devices from Guangdong New Design Biotechnology 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