Identity
- Trade Name
- BIKO MINI ROSA SWITCH LIB./FISSO EUDAMED
- Device Name
- BIKO EUDAMED
- Model / Reference
- BIKO EUDAMED05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054040401886 EUDAMED
- Basic UDI-DI
- 0805571570BIKOX4 EUDAMED
- EMDN Code
- Y121806 PEDAL TRICYCLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Biko Mini Rosa Switch Lib./Fisso by ORMESA S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0805571570BIKOX4 | Class I | Active |
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Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (1)
- EUDAMED 48d7d17e-9d20-48a4-8f09-efd2524e5ee7 61 fields · synced Jul 9, 2026