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Intraveno™

by Mais India Medical Devices Pvt. Ltd. 3 variants

Ref MI/CA/01-000-EModel Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way), I.V. Cannula/Catheter with injection port and with wings 14G

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 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  • Withdrawn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
I.V. Cannula/Catheter
Model / Reference
Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way), MI/CA/01-000-E, I.V. Cannula/Catheter with injection port and with wings 14G
Primary DI / UDI-DI
08904476805126, 08906065486877, 08904476805225, 08906065486907, 08904476805379, 08904476805218, 08904476805317, 08904476805478, 08904476805515, 08906065482749, 08906065482732, 08906065486891, 08904476805164, 08906065486631, 08904476805362, 08904476805270, 08904476805232, 08904476805157
Basic UDI-DI
890606548U03NS, 890606548I01LS
Direct Marketing DI
08904476805126
08906065486877
08904476805225
08906065486907
08904476805379
08904476805218
08904476805317
08904476805478
08904476805515
08906065482749
08906065482732
08906065486891
08904476805164
08906065486631
08904476805362
08904476805270
08904476805232
08904476805157
EMDN Code
U0199, U020199, C0101010102, C0101010101
Device Class
Class IIa
EU market of registration
Belgium
France
Czechia
Bulgaria
Hungary
Ireland
Estonia
Italy
Iceland
Lithuania
Cyprus
Germany
Croatia

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 YesEUDAMEDNoEUDAMED
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No