Shoe cover

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

Ref 15X39cmModel 15X40CM, 39x15CM, 45x16cm （As customized）

EMDN T0208

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: 15X40CM, 39x15CM, 45x16cm （As customized）, 15X39cm

Primary DI / UDI-DI: 06974570453303
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
Disposable tray

Class I
Disposable clothing

Class I
Underpad

Class I
Bandage

Class I
Disposable apron

Class I

See all devices from Wellmien Healthcare Tech. (Suzhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

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

Sources (1)

EUDAMED 524ec1d3-e309-4027-bf21-a69e921d92ff 61 fields · synced 22 Oct 2026