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Archbar Arkı

by Trivitale Saglik Teknolojileri Uretim Anonim Sirketi

Ref ARCH1000

Active European Union

CE MDR

Valid until

12 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86822570SKULLARCH6Z Basic UDI-DI 08682257048275UDI-DIDate4 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1TD-MDR-0029/04/2026/01 Active

    Technical documentation EU MDR

    Certifier
    Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi 2764
    Issued
    13 Apr 2026
    Expires
    12 Apr 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Archbar
Model / Reference
ARCH1000
Primary DI / UDI-DI
08682257048275
Basic UDI-DI
86822570SKULLARCH6Z
EMDN Code
P09120503 Osteosynthesis screw-plate systems
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000039633

Other devices from Trivitale Saglik Teknolojileri Uretim Anonim Sirketi

Properties

  • Implantable

Other properties (13)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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