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Vacuukit

by Teknimed SAS

Ref T060416Model Vacuum Mixing & Injection System for bone cement

Vacuukit (T060416) is a dental bone void filling material (EU MDR Class IIa; FDA Class II; FDA product code LYC, Bone Grafting Material, Synthetic) made by Teknimed, registered in EUDAMED on 8 Apr 2025 (Basic UDI-DI 376017704B21CY) and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760177042919), active (EUDAMED), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number376017704B21CY Basic UDI-DI 03760177042919UDI-DIDate8 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03760177042919 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376017704B21CY registered 8 Apr 2025 Active
  • FDA GUDID UDI-DI 03760177042919 listed 16 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760177042919
  2. Registered EUDAMED 376017704B21CY

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  • Withdrawn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
Vacuukit EUDAMED
Odoncer GUDID
Generic name
Dental bone void filling material, synthetic
Model / Ref / Catalog
Vacuum Mixing & Injection System for bone cement EUDAMED
T060416 EUDAMED
100-1000µm 2cc GUDID
T8210102 GUDID
Primary DI / UDI-DI
03760177042919
Basic UDI-DI
376017704B21CY
FDA product code
LYC
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Dental bone void filling material, synthetic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3930
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution
Size
Weight — 3.2 Gram
Pore Size — 220 Micrometer

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Vacuum Mixing & Injection System for bone cement
T060416
GUDID
100-1000µm 2cc
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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.

Manufacturer details

EUDAMED SRN
FR-MF-000001224

Similar devices in this category

Other devices filed under ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Teknimed

See all devices from Teknimed →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)