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Medpor 9548

by Stryker Leibinger

Ref 9548

Medpor 9548 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-07613252086239), cleared under FDA 510(k) K972034 on 20 Jan 1998 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07613252086239), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972034

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-07613252086239 Basic UDI-DI 07613252086239UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252086239 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972034 Date20 Jan 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07613252086239 registered 5 Nov 2026 Active
  • FDA 510(k) K972034 decided 20 Jan 1998 Active
  • FDA GUDID UDI-DI 07613252086239 listed 24 Aug 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2302-2008 FDA Unclassified (pre-2012) initiated 28 Mar 2008

    The Ocular Conformers were distributed with an expired expiration date.

Timeline

4 dated events

  1. Cleared FDA 510(k) K972034
  2. Recall initiated FDA recalls Z-2302-2008
  3. Listed FDA GUDID 07613252086239
  4. Registered EUDAMED B-07613252086239

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  • Withdrawn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

Trade name
Medpor
Generic name
Ophthalmic conformer
Model / Ref / Catalog
9548
Primary DI / UDI-DI
07613252086239
Basic UDI-DI
B-07613252086239
510(k) Number
FDA product code
HQN
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic conformer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.3130
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Width — 21.0 Millimeter
Length — 24.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Ophthalmic conformer

Cleared under the same submission (K972034)

and 8 more cleared under K972034

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

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