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ACE Bandage

by Young Chemical Co., Ltd. 27 variants

Ref 40253

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 24 Oct 2026. What this means

Overview

ACE Bandage is a medical device used to temporarily hold wounds or dressings in place. This device is approved for use in the United States and is designed to provide a secure and effective way to manage wound care. Made by MedEnvoy Global BV, ACE Bandage is a Class I device that meets all relevant regulatory requirements.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8805178001AW Basic UDI-DI 08805178002830UDI-DIDate3 Apr 2024RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
PLAID Bandage(Dressing)
Model / Reference
40253
Primary DI / UDI-DI
08805178002830
Basic UDI-DI
8805178001AW
EMDN Code
M04010102 Polyurethane (or other material) adhesive dressings, with absorbent pad
Device Class
Class I

Manufacturer details

EUDAMED SRN
KR-MF-000023031
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Young Chemical 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