Skip to content

Fresco

by Romsons Group Private Limited 2 variants

Part of a family of 36 devices: see the family page

Ref A26-13

Fresco (A26-13) is a Class IIa device made by Romsons Group Private Limited, registered in EUDAMED on 28 Jan 2026 (Basic UDI-DI 8907265C014YS), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8907265C014YS Basic UDI-DI 08907265013078UDI-DIDate28 Jan 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Infusion Set
Model / reference
A26-13
Primary DI / UDI-DI
08907265013078
Basic UDI-DI
8907265C014YS
EMDN code
A03010103 Infusion controllers with flow regulator
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000036506
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under INFUSION CONTROLLERS WITH FLOW REGULATOR.

Other devices from Romsons Group Private Limited

See all devices from Romsons Group Private Limited →

Properties

  • Supplied sterile
  • Administering medicine
  • Measuring function
Other properties (11, all answered No)