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Prima 9013.67.134

by Limacorporate

Ref 9013.67.134Model 80333902A016BP

Prima 9013.67.134 is a device classified as Class IIa in the EU and Class I in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333902A016BP) and listed in FDA GUDID since 7 Feb 2024 (UDI-DI 08033390267328), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number80333902A016BP Basic UDI-DI 08033390267328UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390267328 UDI-DI Date7 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333902A016BP registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 08033390267328 listed 7 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390267328
  2. Registered EUDAMED 80333902A016BP

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  • Withdrawn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
PRIMA - Trial Short Stem Plus #4 EUDAMED
Prima GUDID
Generic name
Humeral stem prosthesis trial, reusable
Model / Ref / Catalog
9013.67.134, 80333902A016BP
Primary DI / UDI-DI
08033390267328
Basic UDI-DI
80333902A016BP
FDA product code
LXH
EMDN code
V06010103 Shoulder prostheses testing devices
GMDN term
Humeral stem prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Humeral stem prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES TESTING DEVICES.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

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