Identity
- Trade Name
- BASCH Cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- Cables EUDAMED1600342-001 EUDAMED1600342 FDA UDI
Identifiers
- Catalog Number
- 1600342-001 FDA UDI
- Primary DI / UDI-DI
- 07630055505194 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300555_003_EW EUDAMED
- Direct Marketing DI
- 07630055505194 EUDAMED
- 510(k) Number
- K792159 FDA UDI
- FDA Product Code
- ERL FDA UDI
- EMDN Code
- Z12149099 VARIOUS ENT INSTRUMENTS - 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 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
BASCH 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_003_EW | 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 a408f61f-d111-4461-8a3b-73bf53bdce77 61 fields · synced May 30, 2026
- FDA UDI 04c78a4f-fd25-4b39-850d-aa505ab5c673 34 fields · synced May 30, 2026