← Back to catalogue
Foot control pedals used in combination with surgical power tools to ream, bur,…
EUDAMEDClass I (EU MDR)
Ref MFP-121Ref LEVER - HEKARef FS-271
by Zethon Ltd
Identity
- Device Name
- Foot control pedals used in combination with surgical power tools to ream, bur, drill and cut bone EUDAMED
- Model / Reference
- MFP-121 EUDAMEDLEVER - HEKA EUDAMEDFS-271 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060528013567 EUDAMED05059358044643 EUDAMED05059358036136 EUDAMED
- Basic UDI-DI
- 50605201INT02MAN07WE EUDAMED
- Direct Marketing DI
- 05060528013567 EUDAMED05059358044643 EUDAMED05059358036136 EUDAMED
- EMDN Code
- Z12100980 INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES EUDAMEDZ12100902 DRILLS FOR NEUROSURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Foot control pedals used in combination with surgical power tools to ream, bur,… by Zethon Ltd — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50605201INT02MAN07WE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zethon Ltd
- EUDAMED SRN
- GB-MF-000014309
- Authorised Representative
- De Soutter Medical Limited NL-AR-000000438
Sources (3)
- EUDAMED 33dda8a8-a122-4291-b54b-dacfbbf7bf87 61 fields · synced Aug 1, 2026
- EUDAMED 2d172a9b-eb65-4129-9303-faa0c34e19c2 61 fields · synced May 18, 2026
- EUDAMED 8512cdab-3df5-4abf-8e04-52a1b0f8d823 61 fields · synced May 18, 2026