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IH Transfer Impression Coping

by SEWONMEDIX Inc. 76 variants

Ref AIHTIRH5511D

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8800041300003014W Basic UDI-DIDate12 Apr 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
IH IMPLANT SYSTEM / Laboratory components & Etc.
Model / Reference
AIHTIRH5511D
Primary DI / UDI-DI
08800041353019
Basic UDI-DI
8800041300003014W
EMDN Code
P01020101 Dental implants
Device Class
Class I
Market of Registration
Poland

Manufacturer details

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

Other devices from SEWONMEDIX Inc.

See all devices from SEWONMEDIX Inc. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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