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Quickfix-Skin Stapler

by Qubix Medicare Private Limited 2 variants

Ref SS45W

Quickfix-Skin Stapler (SS45W) is a medical device (EU MDR Class IIa; EMDN category skin staplers) made by Qubix Medicare Private Limited, registered in EUDAMED on 9 Dec 2025 (Basic UDI-DI 890612217SSXC) with CE/MDR certificate 2025-MDR/QS-081/A valid until 2 Dec 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

2 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2025-MDR/QS-081/A Date3 Jun 2026IssuedStatusActive expires 2 Dec 2030

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-081/A Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    3 Jun 2026
    Expires
    2 Dec 2030
    Reason
    Mnf data change

Timeline

3 dated events

  1. Registered EUDAMED 890612217SSXC
  2. Certificate issued EUDAMED 2025-MDR/QS-081/A
  3. Certificate expires EUDAMED 2025-MDR/QS-081/A

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Sterile Skin Stapler
Model / reference
SS45W
Primary DI / UDI-DI
08906122173931
Basic UDI-DI
890612217SSXC
EMDN code
H02010101 Skin staplers, single-use
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000042759
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Similar devices in this category

Other devices filed under SKIN STAPLERS, SINGLE-USE.

Other devices from Qubix Medicare Private Limited

See all devices from Qubix Medicare Private Limited →

Properties

  • Supplied sterile
Other properties (13, all answered No)