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Smr Stemless 9013.55.053

by Limacorporate

Part of a family of 53 devices: see the family page

Ref 9013.55.053Model 80333902A002BC, SMR Stemless - Reamer Small

Smr Stemless 9013.55.053 is a device classified as Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333902A002BC) and listed in FDA GUDID since 26 May 2023 (UDI-DI 08033390108133), active as of 7 Nov 2026.

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

CE MDR 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 Number80333902A002BC Basic UDI-DI 08033390108133UDI-DIDate29 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80333902A002BC Basic UDI-DI 08033390108133UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390108133 UDI-DI Date26 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333902A002BC registered 29 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08033390108133 listed 26 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390108133
  2. Registered EUDAMED 80333902A002BC

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SMR Stemless - Reamer Small EUDAMED
Smr Stemless GUDID
Generic name
Medullary canal orthopaedic reamer, rigid
Model / Ref / Catalog
9013.55.053, 80333902A002BC, SMR Stemless - Reamer Small
Primary DI / UDI-DI
08033390108133
Basic UDI-DI
80333902A002BC, B-08033390108133
FDA product code
PKC
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Medullary canal orthopaedic reamer, rigid
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Medullary canal orthopaedic reamer, rigid

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)