Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Foot switches EUDAMEDCURIS® flow one-pedal-footswitch with push button, explosion proof, 3m cable Class IPX8 FDA UDI
- Model / Reference
- 360115 EUDAMEDFDA UDI
- Description
- CURIS® flow one-pedal-footswitch with push button, explosion proof, 3m cable Class IPX8 FDA UDI
Identifiers
- Catalog Number
- 360115 FDA UDI
- Primary DI / UDI-DI
- ESUM3601150 EUDAMEDFDA UDI
- Basic UDI-DI
- ++ESUMTD15360110DG EUDAMED
- Direct Marketing DI
- ESUM3601150 EUDAMED
- FDA Product Code
- FQH 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
- 880.5475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Foot-switch, electrical
Sutter by Sutter Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (2)
- FDA UDI 752e866b-057c-431d-b6e0-897f63dda31a 35 fields · synced Jun 18, 2026
- EUDAMED 27a9f6ec-cc61-4b71-a72e-d631a5bce83b 61 fields · synced Jun 18, 2026