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Symmetry KARLIN™ 46-3003

by Aspen Surgical Products, Inc.

Part of a family of 119 devices: see the family page

Ref 46-3003

Symmetry KARLIN™ 46-3003 is a Class I device made by Aspen Surgical Products, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 08401132TrayRZ) and listed in FDA GUDID since 7 Dec 2017 (UDI-DI 00887482013656), 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 Number08401132TrayRZ Basic UDI-DI 00887482013656UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887482013656 UDI-DI Date7 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08401132TrayRZ registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00887482013656 listed 7 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887482013656
  2. Registered EUDAMED 08401132TrayRZ

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  • Withdrawn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

Trade name
Symmetry® EUDAMED
Symmetry KARLIN™ GUDID
Generic name
Instrument tray, reusable
Device name
Trays
Model / Ref / Catalog
46-3003
Primary DI / UDI-DI
00887482013656
Basic UDI-DI
08401132TrayRZ
FDA product code
FSM
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)