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Uniglyde

by Unisur Lifecare Private Limited 253 variants

Part of a family of 275 devices: see the family page

Ref 2B70DX40Model 2D70DZ30

Uniglyde (2B70DX40) is a Class III device made by Unisur Lifecare Private Limited, registered in EUDAMED on 3 Dec 2025 (Basic UDI-DI 890430012015ULSSS0024K), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

31 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890430012015ULSSS0024K Basic UDI-DI 08904300130233UDI-DIDate3 Dec 2025RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2025-MDR/QS-004/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030
  • 2025-MDR/TD-004/A Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    8 Jan 2026
    Expires
    31 Jan 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Braided & Coated Polyglycolic Acid Suture
Model / reference
2D70DZ30, 2B70DX40
Primary DI / UDI-DI
08904300130233
Basic UDI-DI
890430012015ULSSS0024K
EMDN code
H010101020101 Polyglycolic acid multifilament with needle for open surgery
Device class
Class III
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000008184
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

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

Other devices from Unisur Lifecare Private Limited

See all devices from Unisur Lifecare Private Limited →

Properties

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