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M/L-10 1128

by Microline Surgical, Inc.

Ref 1128

M/L-10 1128 is a device classified as Class IIb in the EU and Class II in the US made by Microline Surgical, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 081109901DOC002S7) with CE/MDR certificate 3841767CE01 valid until 6 Sep 2031 and listed in FDA GUDID since 13 Nov 2017 (UDI-DI 00811099013334), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

6 Sep 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3841767CE01 Date6 Sep 2026IssuedStatusActive expires 6 Sep 2031
United StatesGUDID listing GUDID Number00811099013334 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081109901DOC002S7 registered 30 Jun 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00811099013334 listed 13 Nov 2017 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3841767CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Sep 2026
    Expires
    6 Sep 2031

Timeline

4 dated events

  1. Listed FDA GUDID 00811099013334
  2. Registered EUDAMED 081109901DOC002S7
  3. Certificate issued EUDAMED 3841767CE01
  4. Certificate expires EUDAMED 3841767CE01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
M/L-10 Clip Cartridge, 8 Clips EUDAMED
M/L-10 GUDID
Generic name
Ligation clip, metallic
Device name
M/L-10 Clip Cartridges
Model / Ref / Catalog
1128
Primary DI / UDI-DI
00811099013334
Basic UDI-DI
081109901DOC002S7
Unit of use DI
00811099013327
FDA product code
GCJ
EMDN code
H03010104 Single-patient multiple clip applier cartridges for open surgery
GMDN term
Ligation clip, metallic
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ligation clip, metallic

Similar devices in this category

Other devices filed under MULTIPLE CLIP APPLIERS FOR OPEN SURGERY.

Other devices from Microline Surgical, Inc.

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    Class II

  • ReNew 3362

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  • ReNew 3946

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  • ReNew 3411

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See all devices from Microline Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)