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Symbotex SYM2515E

by Sofradim Production

Part of a family of 35 devices: see the family page

Ref SYM2515E

Symbotex SYM2515E is a device classified as Class III in the EU and Class II in the US made by Sofradim Production, registered in EUDAMED on 14 May 2026 (Basic UDI-DI 0763000B00003187G) with CE/MDR certificate MDR 729711 valid until 20 Feb 2027 and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 10884521190474), expiring as of 24 Oct 2026.

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

CE MDR

Valid until

20 Feb 2027

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 729711 Date30 Jun 2026IssuedStatusExpiring expires 20 Feb 2027
United StatesGUDID listing GUDID Number10884521190474 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003187G registered 14 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521190474 listed 6 Oct 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 729711 Expiring Supplemented Expires in 99 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    20 Feb 2027
    Reason
    Change approved

Timeline

4 dated events

  1. Listed FDA GUDID 10884521190474
  2. Registered EUDAMED 0763000B00003187G
  3. Certificate issued EUDAMED MDR 729711
  4. Certificate expires EUDAMED MDR 729711

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SymbotexTM EUDAMED
Symbotex GUDID
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Device name
SymbotexTM Composite Mesh
Model / reference
SYM2515E
Primary DI / UDI-DI
10884521190474
Basic UDI-DI
0763000B00003187G
FDA product code
FTL
EMDN code
P900204 Surgical meshes, more than one component
GMDN term
Extra-gynaecological surgical mesh, composite-polymer
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.3300
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 25 Centimeter
Width — 15 Centimeter

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, composite-polymer

Similar devices in this category

Other devices filed under SURGICAL MESHES, MORE THAN ONE COMPONENT.

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)