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Saiph

by MatOrtho Limited 147 variants

Ref 193-725Model SAIPH

Saiph (193-725) is a device classified as Class III in the EU and Class II in the US made by MatOrtho Limited, registered in EUDAMED on 4 Apr 2022 (Basic UDI-DI B-05055455506466), cleared under FDA 510(k) K140222 on 17 Nov 2014 and listed in FDA GUDID since 11 May 2015 (UDI-DI 05055455506466), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140222

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055455506466 Basic UDI-DI 05055455506466UDI-DIDate4 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05055455506466 UDI-DI Date11 May 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140222 Date17 Nov 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055455506466 registered 4 Apr 2022 Active
  • FDA 510(k) K140222 decided 17 Nov 2014 Active
  • FDA GUDID UDI-DI 05055455506466 listed 11 May 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140222
  2. Listed FDA GUDID 05055455506466
  3. Registered EUDAMED B-05055455506466

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Tibial insert
Device name
SAIPH Bearing
Model / Ref / Catalog
SAIPH, 193-725
Primary DI / UDI-DI
05055455506466
Basic UDI-DI
B-05055455506466
510(k) Number
FDA product code
JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN term
Tibial insert
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Legacy device (under a directive)
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.

Manufacturer details

EUDAMED SRN
GB-MF-000007614
Authorised representative
MatOrtho Ireland Limited IE-AR-000006856

Similar devices in this category

Other devices filed under BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS.

Other devices from MatOrtho Limited

See all devices from MatOrtho Limited →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)