Skip to content

Acumed Tr-TS122

by Acumed LLC

Part of a family of 74 devices: see the family page

Ref TR-TS122Model GAUGE

Acumed Tr-TS122 is a device classified as Class IIa in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0806378BUDI41PY) and listed in FDA GUDID since 12 Aug 2019 (UDI-DI 10806378111815), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDI41PY Basic UDI-DI 10806378111815UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378111815 UDI-DI Date12 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDI41PY registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378111815 listed 12 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378111815
  2. Registered EUDAMED 0806378BUDI41PY

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  • Withdrawn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
Anatomical Radial Head EUDAMED
Acumed GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / reference
TR-TS122, GAUGE
Primary DI / UDI-DI
10806378111815
Basic UDI-DI
0806378BUDI41PY
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes
ImplantableEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 10806378111815: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 10806378111815: EUDAMED states No, FDA GUDID states Yes.

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: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)