Domotherm

by Shanghai Careyou Trading Co., Ltd EUDAMED

Active European Union

Ref CY0397, 11587

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number2158318112857E Basic UDI-DI	Date27 Jun 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name: washable upderpad
Domotherm Bettschutzeinlage Waschbar
Model / Reference: CY0397, 11587

Primary DI / UDI-DI: 82158318112855, 21583181115876
Basic UDI-DI: 2158318112857E, 21583181115876
EMDN Code: T04010299, T030502

Device Class: Class I
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000039349
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Careyou Trading Co., Ltd

Domotherm

Class I
emergency blanket

Class I
CareBag

Class I

Properties

Reusable NoEUDAMEDYesEUDAMED
Incorporates Medicinal Product NoEUDAMEDYesEUDAMED

Other properties (11)

Sterile: No
Implantable: 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