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Acne Patch

by Hebei Yuanrun Medical Devices Co., ltd EUDAMED

Active European Union

Ref AP-0012:Heart shape-8mmModel AP-001: Round shape-6mm AP-002: Round shape-8mm AP-003: Round shape-10mm AP-004: Round shape-12mm AP-005: Round shape-14mm AP-006: Round shape-Mixed sizes AP-007:Pressed edge-8mm etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697075700AcnePatchAD Basic UDI-DIDate21 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • 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  • Withdrawn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
Acne Patch
Model / Reference
AP-001: Round shape-6mm AP-002: Round shape-8mm AP-003: Round shape-10mm AP-004: Round shape-12mm AP-005: Round shape-14mm AP-006: Round shape-Mixed sizes AP-007:Pressed edge-8mm etc, AP-0012:Heart shape-8mm
Primary DI / UDI-DI
06970757003613
Basic UDI-DI
697075700AcnePatchAD
EMDN Code
M9099 General and specialist medical devices – other (suture patches see h900102)
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000019188
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Yuanrun Medical Devices Co., ltd

See all devices from Hebei Yuanrun Medical Devices 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