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Surgicose International

by Surgicose International 119 variants

Ref DT-301-32

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G816SURBNFNSR4E Basic UDI-DI +G816DT301320.UDI-DIDate2 Sep 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Surgical Bone Files
Model / Reference
DT-301-32
Primary DI / UDI-DI
+G816DT301320.
Basic UDI-DI
++G816SURBNFNSR4E
Direct Marketing DI
+G816DT301320.
EMDN Code
L99 Surgical instruments, reusable - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
PK-MF-000046901
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Other devices from Surgicose International

See all devices from Surgicose International →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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