Surefit
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- SUREFIT EUDAMEDFDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- Non-orthopedic, Active, Dispersive Electrode, Gel EUDAMEDSUREFIT, DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDI
- Model / Reference
- 410-2100 EUDAMEDFDA UDI410-2200 EUDAMEDFDA UDI
- Description
- SUREFIT, DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR FDA UDI
Identifiers
- Catalog Number
- 410-2200 FDA UDI410-2100 FDA UDI
- Primary DI / UDI-DI
- 30653405033848 EUDAMEDFDA UDI30653405033855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30653405033848 EUDAMEDB-30653405033855 EUDAMED
- 510(k) Number
- K120322 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Electrosurgical return electrode, single-use
Surefit by Conmed Corporation — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120322 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-30653405033848 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (7)
- EUDAMED e2a96972-d497-4229-8f01-e82b40acbe2f 61 fields · synced Jul 23, 2026
- EUDAMED 6db7bcef-23a0-427d-88b9-440e2b16b2e6 61 fields · synced May 17, 2026
- FDA 510(k) K120322 24 fields · synced May 18, 2026
- FDA UDI c8c6998d-5535-44b1-935b-14b512a19818 36 fields · synced May 30, 2026
- FDA UDI dfc7c9cb-183a-494a-8cbf-33a3c85fa78a 36 fields · synced May 30, 2026
- EUDAMED 448f3717-deba-45ec-8b14-9fd537909a4f 61 fields · synced Jul 12, 2026
- EUDAMED fee2e786-0e7c-4bef-b507-a408060e0532 61 fields · synced Jul 23, 2026