Identity
- Trade Name
- RFP-100A Footswitch FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- RFP-100A Footswitch EUDAMED
- Model / Reference
- RFA-FS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00685447000594 EUDAMEDFDA UDI
- Basic UDI-DI
- 06854470002PN EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RFP-100A Footswitch by Baylis Medical Company Inc. — 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 | 06854470002PN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- EUDAMED SRN
- CA-MF-000024361
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (2)
- EUDAMED 99014c2d-03c8-4ca4-b39f-204ea0d29f10 61 fields · synced Jul 30, 2026
- FDA UDI 2f3bf205-12c2-466f-a824-ef965b647848 32 fields · synced May 30, 2026