Skip to content

Fullfield Applicator Btl-754-1

by BTL Industries Limited

Ref 754-AP1F-M

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B108754APEUYJ Basic UDI-DI B108754AP1FMEU00UDI-DIDate30 Jul 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  • Withdrawn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
EXOLASE ONE Applicators
Model / Reference
754-AP1F-M
Primary DI / UDI-DI
B108754AP1FMEU00
Basic UDI-DI
++B108754APEUYJ
Direct Marketing DI
B108754AP1FMEU00
EMDN Code
Z12011019 Multi–platform laser
Device Class
Class IIb
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000034894
Authorised representative
BTL ITALIA S.r.l. IT-AR-000020508

Other devices from BTL Industries Limited

See all devices from BTL Industries Limited →

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