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Gemini_interleave

by Medline Industries, LP 17 variants

Ref GEM1130INT-EU, GEM1154INT-EU, GEM4124INT-EU, GEM4154INT-EU, GEM1148INT-EU, GEM3136INT-EU, GEM3148INT-EU, GEM1124INT-EU

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0888277DC309DNSK9 Basic UDI-DI Date23 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Gemini_interleave
Model / Reference
GEM1130INT-EU, GEM1154INT-EU, GEM4124INT-EU, GEM4154INT-EU, GEM1148INT-EU, GEM3136INT-EU, GEM3148INT-EU, GEM1124INT-EU
Primary DI / UDI-DI
20888277425191, 20888277430294, 20888277425337, 20888277430300, 20888277425221, 20888277425306, 20888277425320, 20888277425184
Basic UDI-DI
0888277DC309DNSK9
Unit of Use DI
10888277425194, 10888277430297, 10888277425330, 10888277430303, 10888277425224, 10888277425309, 10888277425323, 10888277425187
EMDN Code
S010302 Non-woven fabric for sterilisation
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000009717
Authorised representative
Medline International France FR-AR-000001814

Other devices from Medline Industries, Inc.

See all devices from Medline Industries, Inc. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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