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Simpla S

by Coloplast A/S

Ref 346145, 340802, 340805, 21801

Simpla S (346145) is a Class I device made by Coloplast A/S, registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI 5708932297897A5), active as of 22 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5708932297897A5 Basic UDI-DI Date2 Apr 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Simpla S5 bedside drainage bag sterile drainable sample port
Simpla S4 bedside drainage bag sterile drainable sample port
Simpla S2 bedside drainage bag non-sterile non-drainable
Model / reference
346145, 340802, 340805, 21801
Primary DI / UDI-DI
05708932627115, 05701780205191, 05701780205214, 05708932485883, 05708932729628
Basic UDI-DI
5708932297897A5, 5708932297896A3, 57089322978949X
Unit of use DI
05701780063395
EMDN code
A06030301 Urine collection bags
Device class
Class I
EU registration type
Standard device
EU market of registration
Ireland
Finland

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Similar devices in this category

Other devices filed under URINE COLLECTION BAGS.

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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