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Kaulmed

by Bonegraft Biomaterials Co. 5 variants

Ref S-KAUC-HV, S-KAUC-LV-40, KAUKC-SV, KAUVC-LV-20, KAUKC-LV-40, KAUVC-LV-40, KBCAS0108, KAUVC-SV, KBCGW, KVBIS, S-KAUC-LV-20

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08681781333659 Basic UDI-DI Date29 Dec 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Kaulmed HV Radiopaque Bone Cement, PMMA
Kaulmed LV Radiopaque Bone Cement, PMMA, 40g
Kaulmed SV Radiopaque Kyphoplasty Bone Cement, PMMA, 40g
Kaulmed LV Radiopaque Vertebroplasty Bone Cement, PMMA, 20g
Kaulmed LV Radiopaque Kyphoplasty Bone Cement, PMMA, 40g
Kaulmed LV Radiopaque Vertebroplasty Bone Cement, PMMA, 40g
Kaulmed Bone Cement Cavitation and Application Set (2 pcs of Filler and Pusher) Percutaneous Posterior Kyphoplasty, Cavity Creation Expander, Metal-Plastic
Kaulmed SV Radiopaque Vertebroplasty Bone Cement, PMMA, 40g
Kaulmed Bone Cement Applicator Guide Wire (Kirschner wire)
Kaulmed Vertebroplasty, Percutaneous Posterior, Vertebroplasty Bone Interference Set, Metal-Plastic
Kaulmed LV Radiopaque Bone Cement, PMMA, 20g
Model / Reference
S-KAUC-HV, S-KAUC-LV-40, KAUKC-SV, KAUVC-LV-20, KAUKC-LV-40, KAUVC-LV-40, KBCAS0108, KAUVC-SV, KBCGW, KVBIS, S-KAUC-LV-20
Primary DI / UDI-DI
08681781333659, 08681781333635, 08681781333604, 08681781333550, 08681781333598, 08681781333567, 08681781335400, 08681781333574, 08681781335318, 08681781335349, 08681781333987
Basic UDI-DI
B-08681781333659, B-08681781333635, B-08681781333604, B-08681781333550, B-08681781333598, B-08681781333567, B-08681781335400, B-08681781333574, B-08681781335318, B-08681781335349, B-08681781333987
EMDN Code
P900403, P099002
Device Class
Class IIb
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015715

Other devices from Bonegraft Biomaterials Co.

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Properties

  • Sterile
  • Implantable YesEUDAMEDNoEUDAMED

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No