Skip to content

Simpla Plus

by Coloplast A/S 4 variants

Ref 21567, 21592, 21561, 21562, 21572, 21591, 21576

Simpla Plus (21567) is a Class I device made by Coloplast A/S, registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI 57089322978789Z), 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 Number57089322978789Z 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  • Withdrawn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 Plus Syphon leg bag sterile drainable sample port
Simpla Plus leg bag sterile drainable sample port
Simpla Plus bedside drainage bag sterile drainable sample port
Model / reference
21567, 21592, 21561, 21562, 21572, 21591, 21576
Primary DI / UDI-DI
05701780193955, 05701780193948, 05701780194013, 05701780193894, 05701780193900, 05701780193979, 05701780194006, 05708932524841
Basic UDI-DI
57089322978789Z, 57089322978779X, 57089322978929T
EMDN code
A06030301 Urine collection bags
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands
Ireland

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
Other properties (13, all answered No)