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Serial tubing

by Serres Oy

Ref 570918

Serial tubing (570918) is a device classified as Class I in the EU and Class II in the US made by Serres Oy, registered in EUDAMED on 7 Feb 2022 (Basic UDI-DI 6418685SBS57Y) and listed in FDA GUDID since 14 Sep 2026 (UDI-DI 06418685062628), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06418685062628 UDI-DI Date14 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6418685SBS57Y Basic UDI-DI 06418685062628UDI-DIDate7 Feb 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6418685SBS57Y registered 7 Feb 2022 Active
  • FDA GUDID UDI-DI 06418685062628 listed 14 Sep 2026 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Registered EUDAMED 6418685SBS57Y
  2. Listed FDA GUDID 06418685062628

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Suction system canister liner
Model / reference
570918
Primary DI / UDI-DI
06418685062628 EUDAMED
06418685048011 GUDID
Basic UDI-DI
6418685SBS57Y
FDA product code
KDQ
EMDN code
A0680 Drainage and fluid collection devices - accessories
GMDN term
Suction system canister liner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06418685062628
GUDID
06418685048011
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06418685062628; FDA GUDID lists 06418685048011), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000004504

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES.

Other devices from Serres Oy

See all devices from Serres Oy →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)