Identity
- Trade Name
- ValleylabTM EUDAMEDValleylab FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- MONOPOLAR FOOTSWITCH EUDAMEDFDA UDI
- Model / Reference
- E6008 EUDAMEDFDA UDI
- Description
- Monopolar Footswitch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884524001654 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B000016075 EUDAMED
- FDA Product Code
- BWA FDA UDI
- EMDN Code
- K020180 SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
ValleylabTM by Covidien llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763000B000016075 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Covidien llc
- EUDAMED SRN
- US-MF-000028763
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (2)
- EUDAMED a03b7cd1-a87a-4e33-9a1d-bda20dba9c95 61 fields · synced Aug 2, 2026
- FDA UDI 183b3ef7-efd8-4f22-b6e2-2ba308bd152b 35 fields · synced May 30, 2026