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BL Ø3.2*14 mm implant NP

by Proi̇mtech Sağlik Ürünleri̇ Anoni̇m Şi̇rketi̇

Ref PBL3214Model BL Ø3.2*8 mm implant NP

Active European Union

CE MDR

Valid until

21 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SZUTEST Konformitätsbewertungsstelle GmbH

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 Number2975-MED-2614201 Date22 May 2026IssuedStatusActive expires 21 May 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2614201 Active

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    22 May 2026
    Expires
    21 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dental Implant System
Model / Reference
BL Ø3.2*8 mm implant NP, PBL3214
Primary DI / UDI-DI
08681489700043
Basic UDI-DI
86814897proimpDC
Direct Marketing DI
08681489700043
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020130

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Properties

  • Sterile
  • Implantable
  • Sutures

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