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Hekura

by Allion BV h.o.d.n. van Heek Medical 8 variants

Ref UZ4500, HA1200, HA6097, UZ8900, UZ4515-1, UZ8600, UZ9190, HA4067, UZ9010, UZ1010, UZ1315, UZ4515, UZ9910-1, UZ9351, UZ9090, HA1100, SE1090-2, UZ9000, UZ1000

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 Number8715886UrinezakkenEG Basic UDI-DI Date9 Feb 2024RegisteredStatusActive

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  • Withdrawn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 bags
Maternity pad and Underpad
Hekura Set
Model / Reference
UZ4500, HA1200, HA6097, UZ8900, UZ4515-1, UZ8600, UZ9190, HA4067, UZ9010, UZ1010, UZ1315, UZ4515, UZ9910-1, UZ9351, UZ9090, HA1100, SE1090-2, UZ9000, UZ1000
Primary DI / UDI-DI
08715886008423, 08715886008041, 08715886012277, 08715886012031, 08715886028087, 08715886012468, 08715886010204, 08715886012215, 08715886010266, 08715886008515, 08715886011287, 08715886019757, 08715886025536, 08715886010389, 08715886010174, 08715886008010, 08715886019771, 08715886010235, 08715886008485
Basic UDI-DI
8715886UrinezakkenEG, 8715886KraamEnOnderlegUV, 8715886ExterneKathSet46, 8715886UrineafvoerSetGC
Unit of Use DI
08715886012451, 08715886010198, 08715886010259, 08715886010372, 08715886010167, 08715886010228
EMDN Code
A06030301, T04010202, T04010201, A0680, T0499
Device Class
Class I
Class IIb
EU market of registration
Netherlands
Medical Purpose
The Hekura urinary management sets are intended to support the safe, hygienic, and effective management of urinary drainage in adult patients requiring external urinary collection.
The Hekura urinary management sets are intended to support the safe, hygienic, and effective management of urinary drainage in adult patients requiring catheter‑based bladder emptying.

Manufacturer details

EUDAMED SRN
NL-MF-000003490

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Properties

  • Contains Latex NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • 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