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Prolene Spmii

by Ethicon Inc. EUDAMEDGUDID

Active European Union

Ref SPMIIModel PROLENE Polypropylene Mesh and PROLENE Soft Mesh

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 753200 Date9 Sep 2026IssuedStatusActive expires 8 Sep 2031
United StatesGUDID listing GUDID Number10705031050471 UDI-DIDate23 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753200 Active Reissued

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Sep 2026
    Expires
    8 Sep 2031

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Prolene
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device Name
Polypropylene Non-absorbable Synthetic Surgical Mesh
Model / Ref / Catalog
SPMII, PROLENE Polypropylene Mesh and PROLENE Soft Mesh
Primary DI / UDI-DI
10705031050471
Basic UDI-DI
0705031a0136757
FDA Product Code
FTL
EMDN Code
P900202 Polypropylene surgical meshes
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.3300
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No