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Pre-gelled bag 2000 ml

by Serres Oy

Ref 570567-0

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6418685SBS17Q Basic UDI-DI 06418685062567UDI-DIDate28 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06418685062567 UDI-DI Date5 Feb 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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

Trade Name
Pre-gelled bag 2000 ml EUDAMED
Pre-gelled bag, folded, 2000 ml GUDID
Generic Name
Suction system canister liner
Device Name
Suction bags
Model / Reference
570567-0
Primary DI / UDI-DI
06418685062567 EUDAMED
06418685047014 GUDID
Basic UDI-DI
6418685SBS17Q
FDA Product Code
KDQ
EMDN Code
A060301 Collection bags and other containers for drainages and fistulas, single use
GMDN Term
Suction system canister liner
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6740
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06418685062567
GUDID
06418685047014
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000004504

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 (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No