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Tcc-Ez® TCC23005

by Acell, Inc.

Part of a family of 19 devices: see the family page

Ref TCC2-3005

Tcc-Ez® TCC23005 is a Class I device made by Acell, Inc., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI 0809958B0080TT8D) and listed in FDA GUDID since 23 Oct 2018 (UDI-DI 00809958005613), active as of 24 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0809958B0080TT8D Basic UDI-DI 00809958005613UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00809958005613 UDI-DI Date23 Oct 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0809958B0080TT8D registered 16 Jun 2026 Active
  • FDA GUDID UDI-DI 00809958005613 listed 23 Oct 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00809958005613
  2. Registered EUDAMED 0809958B0080TT8D

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  • Withdrawn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
Tcc-Ez®
Generic name
Cast boot
Device name
Total Contact Cast
Model / Ref / Catalog
TCC2-3005 EUDAMED
TCC23005 GUDID
Primary DI / UDI-DI
00809958005613
Basic UDI-DI
0809958B0080TT8D
FDA product code
ITG
EMDN code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Cast boot
Device class
Class I
Regulation number
890.3025
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TCC2-3005
GUDID
TCC23005

Related devices

Category: Cast boot

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from Acell, Inc.

See all devices from Acell, Inc. →

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)