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Large Tip

by Classys

Ref 1590-00001-301

Large Tip (1590-00001-301) is a Class I device made by CLASSYS Inc., registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 88000169ST1XB), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000169ST1XB Basic UDI-DI 08800016900835UDI-DIDate1 Jul 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Abration Unit
Model / reference
1590-00001-301
Primary DI / UDI-DI
08800016900835
Basic UDI-DI
88000169ST1XB
EMDN code
Z12040299 General medicine therapeutic treatment instruments - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000010116
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

Other properties (14, all answered No)