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Breeze- Airclean Dental Mirror

by Acme Tooling Technology Co., Ltd. 22 variants

Ref AMYH180048Model M3

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987927M325 Basic UDI-DI 04719879275605UDI-DIDate17 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Breeze- Airclean Dental Mirror
Model / Reference
M3, AMYH180048
Primary DI / UDI-DI
04719879275605
Basic UDI-DI
471987927M325
EMDN Code
L160201 Dental mirrors and handles, reusable
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
TW-MF-000044777
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Acme Tooling Technology Co., Ltd.

See all devices from Acme Tooling Technology 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