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Modular Bipolar Head

by Biotech GmbH 123 variants

Ref 017-1600-3822Model Biotech Modular Head System

Active European Union

CE MDD

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

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/MDD NumberB-04049852203289 Basic UDI-DI 04049852203289UDI-DIDate22 Jul 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

GermanyCzech RepublicHungaryBulgariaCroatiaGreece
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 6 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Bulgaria
  • Croatia
  • Czechia
  • Germany since 22 Dec 2003
  • Greece
  • Hungary since 3 Aug 2006

Last checked 31 Oct 2026.

Specification

EUDAMED

Model / reference
Biotech Modular Head System, 017-1600-3822
Primary DI / UDI-DI
04049852203289
Basic UDI-DI
B-04049852203289
EMDN code
P090804050299 Femoral heads for primary implant of total prostheses - other
Device class
Class III
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000023586

Other devices from Biotech GmbH

See all devices from Biotech GmbH →

Properties

  • Supplied sterile
  • Implantable

Other properties (12)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No