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Oral Ulcer Patch

by Zhejiang Hangbiao Medical Products Co., Ltd.

Ref HBKModel Circular: diameter range Φ0.8 cm–Φ1.4 cm; Square: length 0.8 cm–1.4 cm, width 0.8 cm–1.4 cm; Custom shapes: maximum external dimensions 0.8 cm–1.7 cm

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 linked in EUDAMED

A group certificate may exist

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697169661HBKUX Basic UDI-DI 06971696613864UDI-DIDate21 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Oral Ulcer Patch
Model / Reference
Circular: diameter range Φ0.8 cm–Φ1.4 cm, Square: length 0.8 cm–1.4 cm, width 0.8 cm–1.4 cm, Custom shapes: maximum external dimensions 0.8 cm–1.7 cm, HBK
Primary DI / UDI-DI
06971696613864
Basic UDI-DI
697169661HBKUX
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000041389
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Zhejiang Hangbiao Medical Products Co., Ltd.

See all devices from Zhejiang Hangbiao Medical Products Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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