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OPTIFUSE® 1.0 mL

by Teknimed SAS

Ref B0100Model Synthetic Bone Substitute

OPTIFUSE® 1.0 mL (B0100) is a Class III device made by Teknimed, registered in EUDAMED on 28 Jun 2023 (Basic UDI-DI 376017704B09DA), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376017704B09DA Basic UDI-DI 03760177046894UDI-DIDate28 Jun 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Nanogel
Model / reference
Synthetic Bone Substitute, B0100
Primary DI / UDI-DI
03760177046894
Basic UDI-DI
376017704B09DA
EMDN code
P900401 Bone and tendon replacement devices
Device class
Class III
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001224

Similar devices in this category

Other devices filed under IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES - VARIOUS.

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Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)