Shoe cover

by Wellmien Healthcare Tech. (Suzhou) Co., Ltd. EUDAMED

Active European Union

Ref 15X40cmModel 15X40CM, 39x15CM, 45x16cm （As customized）

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697457045SC001HM Basic UDI-DI	Date17 Mar 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: 15X40CM, 39x15CM, 45x16cm （As customized）

Primary DI / UDI-DI: 06974570453310
Basic UDI-DI: 697457045SC001HM
EMDN Code: T0208 Shoe covers (excluding personal protective equipment - PPE)

Device Class: Class I
Market of Registration: Czechia

Manufacturer details

EUDAMED SRN: CN-MF-000010365
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Wellmien Healthcare Tech. (Suzhou) Co., Ltd.

Surgical mask

Class I
Shoe cover

Class I
Disposable tray

Class I
Disposable clothing

Class I
Underpad

Class I
Bandage

Class I

See all devices from Wellmien Healthcare Tech. (Suzhou) 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