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IH2 SLA Fixture

by SEWONMEDIX Inc. 87 variants

Ref BIH2FR4007SModel IH IMPLANT SYSTEM

Active European Union

CE MDD

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 24 Oct 2026. What this means

Overview

Our IH2 SLA Fixture is a cutting-edge medical device designed for precise bone cementing and implant placement. With its advanced self-testing capabilities, this fixture ensures accurate and reliable results. The IH2 SLA Fixture is used in various medical specialties, including orthopedic surgery and dental implants.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800041301584 Basic UDI-DI 08800041301584UDI-DIDate10 Aug 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
IH IMPLANT SYSTEM, BIH2FR4007S
Primary DI / UDI-DI
08800041301584
Basic UDI-DI
B-08800041301584
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000016194
Authorised representative
Advena Limited MT-AR-000000234

Other devices from SEWONMEDIX Inc.

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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