Plantar Fasciitis Splint

by Guangdong New Design Biotechnology Co., Ltd 4 variants

Ref ZX1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697765270ZX1YX Basic UDI-DI 06977652700135UDI-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Withdrawn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: ZX1

Primary DI / UDI-DI: 06977652700135
Basic UDI-DI: 697765270ZX1YX
EMDN Code: Y061203, Y061299

Device Class: Class I
EU market of registration: Spain

Manufacturer details

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

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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