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Onatec OE341161

by Surgical Specialties México, S. de R.L. de C.V.

Ref OE341161

Onatec OE341161 is a device classified as Class III in the EU and Class II in the US made by Surgical Specialties México, S. de R.L. de C.V., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00848782052103) and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 00848782052103), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848782052103 Basic UDI-DI 00848782052103UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848782052103 UDI-DI Date2 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00848782052103 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00848782052103 listed 2 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848782052103
  2. Registered EUDAMED B-00848782052103

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Onalene EUDAMED
Onatec GUDID
Generic name
Polyolefin/fluoropolymer suture, monofilament
Device name
PPN Sutures
Model / Ref / Catalog
OE341161
Primary DI / UDI-DI
00848782052103
Basic UDI-DI
B-00848782052103
FDA product code
GAW
EMDN code
H010201010401 Polypropylene monofilament with needle for open surgery
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5010
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Polyolefin/fluoropolymer suture, monofilament

Similar devices in this category

Other devices filed under POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Surgical Specialties México, S. de R.L. de C.V.

See all devices from Surgical Specialties México, S. de R.L. de C.V. →

Properties

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