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Hydense™

by Biosan Biyoteknoloji San. ve Dış Tic. A.Ş. EUDAMED

Active European Union

Ref BHA253HCA

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683465881593 Basic UDI-DIDate15 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
Hydense™ 2.5% Sterile Absorbable Hyaluronic Acid Containing Intra Articular Gel Implant 75mg/3mL
Model / Reference
BHA253HCA
Primary DI / UDI-DI
08683465881593
Basic UDI-DI
B-08683465881593
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038203

Other devices from Biosan Biyoteknoloji San. ve Dış Tic. A.Ş.

See all devices from Biosan Biyoteknoloji San. ve Dış Tic. A.Ş. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No