Identity
- Trade Name
- BIKO SMALL BLU DIFF.PIGN.FISSO EUDAMEDBIKO FDA UDI
- Generic Name
- Assistive foot-propelled tricycle FDA UDI
- Device Name
- BIKO EUDAMEDMedical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system. FDA UDI
- Model / Reference
- BIKO EUDAMED05 EUDAMEDBIKO SMALL BLU DIFF.PIGN.FISSO FDA UDI
- Description
- Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715708620 EUDAMEDFDA UDI
- Basic UDI-DI
- 0805571570BIKOX4 EUDAMED
- FDA Product Code
- ION FDA UDI
- EMDN Code
- Y121806 PEDAL TRICYCLES EUDAMED
- GMDN Term
- Assistive foot-propelled tricycle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Biko Small Blu Diff.pign.fisso by ORMESA S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0805571570BIKOX4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (2)
- EUDAMED c98a4e28-cd15-4653-9ab5-bfc6338232e2 61 fields · synced Jul 22, 2026
- FDA UDI 2a3fc126-49bb-4d0a-8d58-9c8d28e6fd15 33 fields · synced May 26, 2026