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HYDRAFIL Delivery System

by ReGelTec Inc. United States EUDAMED

Ref 610-0005Model 610-0003 EMDN P09070201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0195893BM2022FG Basic UDI-DIDate21 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HYDRAFIL Procedure Kit
Model / Reference
610-0003, 610-0005
Primary DI / UDI-DI
00195893039395
Basic UDI-DI
0195893BM2022FG
EMDN Code
P09070201 Disc prostheses
Device Class
Class III
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000025182
Authorised representative
Advena Limited MT-AR-000000234

Other devices from ReGelTec Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: 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

Sources (1)

  • EUDAMED 65abdbc8-f63f-48bb-aff2-dbb02b9c2350 61 fields · synced 24 Oct 2026