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Pegelak

by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 167 variants

Part of a family of 166 devices: see the family page

Ref L8500Model With or without needle(s)

Pegelak (L8500) is a Class III device made by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş., registered in EUDAMED on 4 May 2026 (Basic UDI-DI 8698147S110L0TY) with CE/MDR certificate MDR 00115-B valid until 26 Oct 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

26 Oct 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8698147S110L0TY Basic UDI-DI 08698147924550UDI-DIDate4 May 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 00115-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    27 Oct 2025
    Expires
    26 Oct 2030
  • MDR 00115-B Active

    Technical documentation EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    12 Dec 2025
    Expires
    26 Oct 2030

Timeline

5 dated events

  1. Certificate issued EUDAMED MDR 00115-A
  2. Certificate issued EUDAMED MDR 00115-B
  3. Registered EUDAMED 8698147S110L0TY
  4. Certificate expires EUDAMED MDR 00115-B
  5. Certificate expires EUDAMED MDR 00115-A

Coverage

1 jurisdiction

Türkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

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

  • Türkiye since 11 Jul 2006

Last checked 30 Oct 2026.

Specification

EUDAMED

Model / reference
With or without needle(s), L8500
Primary DI / UDI-DI
08698147924550
Basic UDI-DI
8698147S110L0TY
EMDN code
H010101020201, H010101020202
Device class
Class III
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016026

Similar devices in this category

Other devices filed under POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.

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    Class III

  • Politer

    Class III

  • Propilen

    Class III

  • Xnat-Pedesente

    Class III

See all devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. →

Properties

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