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Orthopaedic Surgical Instrument - Container

by Buxton BioMedical, inc. 49 variants

Ref 91-5302

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B768TF5TM Basic UDI-DI +B76891530207UDI-DIDate7 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Orthopaedic Surgical Instrument - Container
Model / Reference
91-5302
Primary DI / UDI-DI
+B76891530207
Basic UDI-DI
++B768TF5TM
EMDN Code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000035059
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Buxton Biomedical, Inc.

See all devices from Buxton Biomedical, Inc. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • 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