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URINE COLLECTION BAG, CLOSED-ENDED WEARABLE (With Measured Volume meter) 250ml

by SBRG MedTech Pvt. Ltd.

Ref 03010301Model URINE COLLECTION BAG , CLOSED-ENDED WEARABLE (With Measured Volume meter)

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 Number89061712503035S Basic UDI-DI 08906171253493UDI-DIDate25 Sep 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  • Withdrawn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
URINE COLLECTION BAG, CLOSED-ENDED WEARABLE (With Measured Volume meter)
Model / Reference
URINE COLLECTION BAG, CLOSED-ENDED WEARABLE (With Measured Volume meter), 03010301
Primary DI / UDI-DI
08906171253493
Basic UDI-DI
89061712503035S
EMDN Code
A06030302 Hourly diuresis measurement sets
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000038015
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SBRG MedTech Pvt. Ltd.

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Properties

  • Sterile
  • Administering Medicine
  • Measuring Function

Other properties (10)

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