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One-step method drainage kit

by Balton Sp. z o.o. 10 variants

Ref OSD16FP

One-step method drainage kit (OSD16FP) is a Class IIa device made by Balton Sp. z o.o., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-05901297141108), active as of 24 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05901297141108 Basic UDI-DI Date25 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
One-step method drainage kit
Model / reference
OSD16FP
Primary DI / UDI-DI
05901297141108, 05901297275131
Basic UDI-DI
B-05901297141108, B-05901297275131
EMDN code
A060299 Percutaneous drainage systems - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000010568

Similar devices in this category

Other devices filed under PERCUTANEOUS DRAINAGE SYSTEMS - OTHER.

Other devices from Balton Sp. z o.o.

See all devices from Balton Sp. z o.o. →

Properties

  • Supplied sterile
Other properties (13, all answered No)