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Multi-Purpose Drainage Catheter Ⅱ

by SUNGWON MEDICAL Co., Ltd.

Ref 2026-0115Model PI0610-RL(30)

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800059400002 Basic UDI-DI 08800059400002UDI-DIDate13 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Multi-Purpose Drainage Catheter
Model / Reference
PI0610-RL(30), 2026-0115
Primary DI / UDI-DI
08800059400002
Basic UDI-DI
B-08800059400002
EMDN Code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000014752
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

Other devices from SUNGWON MEDICAL Co., Ltd.

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No