Identity
- Trade Name
- One-pedal footswitch, wireless EUDAMED
- Device Name
- FOOTSWITCH FOR ELECTROSURGICAL DEVICE EUDAMED
- Model / Reference
- 100-311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907763211153 EUDAMED
- Basic UDI-DI
- 59077632-TF9FOOTSWITCH-UM EUDAMED
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
One-pedal footswitch, wireless by Emed Sp. Z O. O. Sp. K. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 59077632-TF9FOOTSWITCH-UM | Class I | Active |
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Manufacturer
- Manufacturer
- Emed Sp. Z O. O. Sp. K.
- EUDAMED SRN
- PL-MF-000012648
Sources (1)
- EUDAMED 684da246-37ba-48af-b21a-9c2ca368e373 61 fields · synced Jul 31, 2026