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Surgical Glue Gubran 2 Surgery

by Gem SRL EUDAMED

Active European Union

Ref G-NB2S-25-SURModel G-NB-2;G-NB2-75;G-NB2-60; G-NB2-50; G-NB2-35 ;G-NB2S-25

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0019240225 Date12 Mar 2025IssuedStatusActive expires 15 May 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0019240225 Supplemented

    Quality management system EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    12 Mar 2025
    Expires
    15 May 2029
    Reason
    Add device or group
  • CVD0027240225 Supplemented

    Technical documentation EU MDR

    Notified body
    ISTITUTO SUPERIORE DI SANITA' 0373
    Issued
    12 Mar 2025
    Expires
    15 May 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Surgical Glue Glubran 2
Model / Reference
G-NB-2, G-NB2-75, G-NB2-60, G-NB2-50, G-NB2-35, G-NB2S-25, G-NB2S-25-SUR
Primary DI / UDI-DI
08031902000968
Basic UDI-DI
803190219X
EMDN Code
H90010102 Synthetic glues
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000012892

Other devices from Gem SRL

See all devices from Gem SRL →

Properties

Show properties
  • Sterile
  • Implantable
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