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TEMA Elbow 9015.75.150

by Limacorporate

Part of a family of 85 devices: see the family page

Ref 9015.75.150Model TEMA Elbow - Trial Ulnar Stem #U7, 80333902A018BT

TEMA Elbow 9015.75.150 is a device classified as Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390138963) and listed in FDA GUDID since 24 May 2019 (UDI-DI 08033390138963), 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/MDR EUDAMED NumberB-08033390138963 Basic UDI-DI 08033390138963UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390138963 Basic UDI-DI 08033390138963UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390138963 UDI-DI Date24 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08033390138963 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08033390138963 listed 24 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390138963
  2. Registered EUDAMED B-08033390138963

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
TEMA Elbow - Trial Ulnar Stem #U7 EUDAMED
TEMA Elbow GUDID
Generic name
Elbow ulna prosthesis trial
Model / Ref / Catalog
9015.75.150, TEMA Elbow - Trial Ulnar Stem #U7, 80333902A018BT
Primary DI / UDI-DI
08033390138963
Basic UDI-DI
B-08033390138963, 80333902A018BT
FDA product code
JDC, JDB
EMDN code
V06010199 Orthopaedic prostheses testing devices - other
GMDN term
Elbow ulna prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3150, 888.3160
EU registration type
Legacy device (under a directive)
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 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: Elbow ulna prosthesis trial

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
  • Lot / batch number
Other properties (21, all answered No)