Hydrocolloid Patch

by Dongguan Xinhongke Adhesive Products Co., Ltd. 17 variants

Ref XH818Model XHK320 XHK302 XHK316 XHK360 XHK308 XHK307 XH717 XH705 XH827 XH806 XH818 XH737 763 701 7035 7070 7077

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	Number698010006HCPJD Basic UDI-DI 06980100060316UDI-DI	Date19 May 2026Registered	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Withdrawn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

Device Name: Hydrocolloid Patch
Model / Reference: XHK320 XHK302 XHK316 XHK360 XHK308 XHK307 XH717 XH705 XH827 XH806 XH818 XH737 763 701 7035 7070 7077, XH818

Primary DI / UDI-DI: 06980100060316
Basic UDI-DI: 698010006HCPJD
EMDN Code: M04040301 Hydrocolloid dressings, non-combined

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000054518
Authorised representative: HyperCert Limited B.V. NL-AR-000047746

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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