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Menix®

by S.B.M. SAS 5 variants

Ref MEN9000412Model Metal instrument

Menix® (MEN9000412) is a Class I device made by S.B.M. SAS, registered in EUDAMED on 23 Oct 2023 (Basic UDI-DI 376015400DT2020021TP) and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 03760304680762), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376015400DT2020021TP Basic UDI-DI 03760304680762UDI-DIDate23 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03760304680762 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376015400DT2020021TP registered 23 Oct 2023 Active
  • FDA GUDID UDI-DI 03760304680762 listed 25 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760304680762
  2. Registered EUDAMED 376015400DT2020021TP

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  • Withdrawn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

Generic name
Bone file/rasp, manual, reusable
Device name
Metal instrument for meniscus repair
Model / Ref / Catalog
Metal instrument, MEN9000412, MENIX rasp
Primary DI / UDI-DI
03760304680762
Basic UDI-DI
376015400DT2020021TP
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Metal instrument
MEN9000412
GUDID
MENIX rasp

Manufacturer details

EUDAMED SRN
FR-MF-000000214

Related devices

Category: Surgical implant template, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.B.M. SAS

See all devices from S.B.M. SAS →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)