Identity
- Trade Name
- S120 Cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- S120 Cable EUDAMED
- Model / Reference
- S120 Cable EUDAMED1600629-001 EUDAMED1600629 FDA UDI
Identifiers
- Catalog Number
- 1600629-001 FDA UDI
- Primary DI / UDI-DI
- 07630055505576 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300555_015_F9 EUDAMED
- Direct Marketing DI
- 07630055505576 EUDAMED
- FDA Product Code
- ERL FDA UDINLY FDA UDIEQJ FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4250 FDA UDI874.4140 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
Moist Heat or Steam Sterilization FDA UDI
S120 Cable 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_015_F9 | 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 f49e9f84-7a3c-4ecf-b142-9ab14ea8eda5 61 fields · synced Jul 9, 2026
- FDA UDI 0d7b0bb0-a028-4809-800d-698d3eb68d79 33 fields · synced May 30, 2026