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Prolene Spms

by Ethicon Inc.

Part of a family of 20 devices: see the family page

Ref SPMSModel PROLENE Polypropylene Mesh and PROLENE Soft Mesh

Prolene Spms is a device classified as Class III in the EU and Class II in the US made by Ethicon Inc., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 0705031a0136757) with CE/MDR certificate MDR 753200 valid until 8 Sep 2031 and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10705031050495), active as of 24 Oct 2026.

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

CE MDR

Valid until

8 Sep 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 753200 Date9 Sep 2026IssuedStatusActive expires 8 Sep 2031
United StatesGUDID listing GUDID Number10705031050495 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0705031a0136757 registered 13 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10705031050495 listed 1 Sep 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 753200 Active Reissued

    Technical documentation EU MDR

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

Timeline

4 dated events

  1. Listed FDA GUDID 10705031050495
  2. Registered EUDAMED 0705031a0136757
  3. Certificate issued EUDAMED MDR 753200
  4. Certificate expires EUDAMED MDR 753200

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  • Withdrawn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
Prolene
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device name
Polypropylene Non-absorbable Synthetic Surgical Mesh
Model / Ref / Catalog
SPMS, PROLENE Polypropylene Mesh and PROLENE Soft Mesh
Primary DI / UDI-DI
10705031050495
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
EU registration type
Standard device
EU 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

Device class is stated on each registry's own scale: Class III 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: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Similar devices in this category

Other devices filed under POLYPROPYLENE SURGICAL MESHES.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

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