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Maisuro™

by Mais India Medical Devices Pvt. Ltd.

Ref MI/CA/01-000-EModel Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way)

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890606548U03NS Basic UDI-DI Date12 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Foley Balloon Catheter
Model / Reference
Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way), MI/CA/01-000-E
Primary DI / UDI-DI
08906065489120, 08906065489069, 08906065489021, 08906065489083, 08906065489106, 08906065489007, 08906065489168, 08906065488956, 08906065488963, 08906065489090, 08906065489045, 08906065489014, 08906065489151, 08906065489038, 08906065489113, 08906065489144, 08906065488987, 08906065489052, 08906065489076, 08906065489137, 08906065488970, 08906065488994
Basic UDI-DI
890606548U03NS
Direct Marketing DI
08906065489120
08906065489069
08906065489021
08906065489083
08906065489106
08906065489007
08906065489168
08906065488956
08906065488963
08906065489090
08906065489045
08906065489014
08906065489151
08906065489038
08906065489113
08906065489144
08906065488987
08906065489052
08906065489076
08906065489137
08906065488970
08906065488994
EMDN Code
U0199, U020199
Device Class
Class IIa
EU market of registration
Belgium
Germany
Cyprus
Croatia
Latvia
Ireland
Greece
Bulgaria
Czechia
Denmark
Iceland

Manufacturer details

EUDAMED SRN
IN-MF-000021842
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Mais India Medical Devices Pvt. Ltd.

See all devices from Mais India Medical Devices Pvt. Ltd. →

Properties

  • Sterile
  • Contains Latex NoEUDAMEDYesEUDAMED

Other properties (11)

  • Implantable: No
  • Reusable: 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