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Foot control pedals used in combination with surgical power tools to ream, bur,…
EUDAMEDFDA UDIClass I (EU MDR)
Ref FS-270
by Zethon Ltd
Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot control pedals used in combination with surgical power tools to ream, bur, drill and cut bone EUDAMEDFS-270 FOOT SWITCH - CORDED FDA UDI
- Model / Reference
- FS-270 EUDAMED18580 FDA UDI
- Description
- FS-270 FOOT SWITCH - CORDED FDA UDI
Identifiers
- Catalog Number
- 18580 FDA UDI
- Primary DI / UDI-DI
- 05059358034453 EUDAMEDFDA UDI
- Basic UDI-DI
- 50605201INT02MAN07WE EUDAMED
- Direct Marketing DI
- 05059358034453 EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- Z12100980 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Foot control pedals used in combination with surgical power tools to ream, bur,… by Zethon Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50605201INT02MAN07WE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (2)
- EUDAMED 46a3f3a8-bb07-4d02-8fa8-128dac93afda 61 fields · synced Jul 10, 2026
- FDA UDI 01e0d461-10d0-477c-b550-e9878f05b321 35 fields · synced May 29, 2026