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TEMA Elbow 9015.04.091

by Limacorporate

Ref 9015.04.091Model 80333901R002EQ, TEMA Elbow - Distal Humeral Broach #H9 RIGHT

TEMA Elbow 9015.04.091 is a device classified as Class I in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333901R002EQ) and listed in FDA GUDID since 24 May 2019 (UDI-DI 08033390138314), 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 Number80333901R002EQ Basic UDI-DI 08033390138314UDI-DIDate29 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80333901R002EQ Basic UDI-DI 08033390138314UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390138314 UDI-DI Date24 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80333901R002EQ registered 29 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08033390138314 listed 24 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033390138314
  2. Registered EUDAMED 80333901R002EQ

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  • Withdrawn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
TEMA Elbow - Distal Humeral Broach H.9 Right EUDAMED
TEMA Elbow - Distal Humeral Broach #H9 RIGHT EUDAMED
TEMA Elbow GUDID
Generic name
Orthopaedic broach
Model / Ref / Catalog
9015.04.091, 80333901R002EQ, TEMA Elbow - Distal Humeral Broach #H9 RIGHT
Primary DI / UDI-DI
08033390138314
Basic UDI-DI
80333901R002EQ, B-08033390138314
FDA product code
JDB, JDC
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Orthopaedic broach
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3160, 888.3150
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 I
GUDID
Class II

Related devices

Category: Orthopaedic broach

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)