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Biko Small Rosso Ruota Libera

by ORMESA S.r.l. 2 variants

Ref 05Model BIKO

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08054040402876 UDI-DI Date1 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0805571570BIKOX4 Basic UDI-DI 08054040402876UDI-DIDate24 Jul 2025RegisteredStatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Biko Small Rosso Ruota Libera EUDAMED
Biko GUDID
Generic Name
Assistive foot-propelled tricycle
Model / Reference
BIKO EUDAMED
05 EUDAMED
BIKO SMALL ROSSO RUOTA LIBERA GUDID
Primary DI / UDI-DI
08054040402876
Basic UDI-DI
0805571570BIKOX4
FDA Product Code
ION
EMDN Code
Y121806 Pedal tricycles
GMDN Term
Assistive foot-propelled tricycle
Device Class
Class I
Regulation Number
890.5370
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BIKO
05
GUDID
BIKO SMALL ROSSO RUOTA LIBERA

Manufacturer details

EUDAMED SRN
IT-MF-000034824

Other devices from ORMESA S.r.l.

See all devices from ORMESA S.r.l. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No