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Profimed

by Θ.καζαντζιδης Αε - Medipac 124 variants

Part of a family of 124 devices: see the family page

Ref PR434

Profimed (PR434) is a Class III device made by Θ.καζαντζιδης Αε - Medipac, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 5206913PROFIMED8Q) with CE/MDR certificate C07 GR027637 2412 valid until 19 Dec 2029, active as of 26 Oct 2026.

Active European Union

CE MDR

Valid until

19 Dec 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier HTCert (Health Technology Certification Ltd)

Trust

Unverified

Source EUDAMED, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5206913PROFIMED8Q Basic UDI-DI 05206913009085UDI-DIDate20 May 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • C07 GR027637 2412 Active

    Technical documentation EU MDR

    Certifier
    HTCert (Health Technology Certification Ltd) 2803
    Issued
    16 Mar 2026
    Expires
    19 Dec 2029

Timeline

3 dated events

  1. Certificate issued EUDAMED C07 GR027637 2412
  2. Registered EUDAMED 5206913PROFIMED8Q
  3. Certificate expires EUDAMED C07 GR027637 2412

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 31 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 6 Feb 2012
  • Belgium since 4 Jan 2027
  • Bulgaria since 6 Feb 2012
  • Croatia since 4 Jan 2027
  • Cyprus since 6 Feb 2012
  • Czechia since 4 Jan 2027
  • Denmark since 4 Jan 2027
  • Estonia since 4 Jan 2027
  • Finland since 4 Jan 2027
  • France since 6 Feb 2012
  • Germany since 6 Feb 2012
  • Greece since 4 Jan 2011
  • Hungary since 4 Jan 2027
  • Iceland since 4 Jan 2027
  • Ireland since 4 Jan 2027
  • Italy since 6 Feb 2012
  • Latvia since 4 Jan 2027
  • Liechtenstein since 4 Jan 2027
  • Lithuania since 4 Jan 2027
  • Luxembourg since 4 Jan 2027
  • Malta since 4 Jan 2027
  • Netherlands since 4 Jan 2027
  • Northern Ireland since 4 Jan 2027
  • Norway since 4 Jan 2027
  • Poland since 4 Jan 2027
  • Portugal since 6 Feb 2012
  • Romania since 6 Feb 2012
  • Slovakia since 4 Jan 2027
  • Slovenia since 4 Jan 2027
  • Spain since 6 Feb 2012
  • Sweden since 6 Feb 2012

Last checked 23 Oct 2026.

Specification

EUDAMED

Model / reference
PR434
Primary DI / UDI-DI
05206913009085
Basic UDI-DI
5206913PROFIMED8Q
EMDN code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
Device class
Class III
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000027637

Similar devices in this category

Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE.

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Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)