Identity
- Trade Name
- ORIGO Foot Pedal EUDAMEDFDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Origo Foot Pedal EUDAMED
- Model / Reference
- 1601082 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1601082-001 FDA UDI
- Primary DI / UDI-DI
- 07630055511751 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300555_024_FB EUDAMED
- Direct Marketing DI
- 07630055511751 EUDAMED
- FDA Product Code
- HBC FDA UDIHBE FDA UDINLY FDA UDIERL FDA UDIEQJ FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4360 FDA UDI882.4310 FDA UDI874.4140 FDA UDI874.4250 FDA UDI
- Market of Registration
- France 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ORIGO Foot Pedal by Bien-Air Surgery Sa — 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 | 76300555_024_FB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
- EUDAMED SRN
- CH-MF-000016376
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (2)
- EUDAMED 65ad5992-b39f-44b3-917f-44cea995f7a9 61 fields · synced Jul 12, 2026
- FDA UDI eabded6c-c083-4e9d-a0b2-778a004297b7 33 fields · synced May 30, 2026