Identity
- Trade Name
- EUSRA RF Electrode EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- EUSRA RF Electrode EUDAMEDThe EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
- Model / Reference
- 19-05E EUDAMEDFDA UDI18-15E EUDAMED
- Description
- The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306766601 EUDAMEDFDA UDI08809306762306 EUDAMED
- Basic UDI-DI
- 880930676EUSRA_E7F EUDAMEDB-08809306762306 EUDAMEDB-08809306766601 EUDAMED
- 510(k) Number
- K181249 FDA UDI
- FDA Product Code
- GEI FDA UDIJOS FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Bulgaria EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
Dimensions & Sizes
- Size
- Needle Gauge — 19 Gauge FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
EUSRA RF Electrode by Starmed Co., Ltd — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880930676EUSRA_E7F | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 880930676EUSRA_E7F | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED d23117f9-00b9-4c81-95be-c691b2280edd 61 fields · synced Oct 1, 2026
- EUDAMED 58ea6c07-7f1a-434c-9c72-d2bd4d9392f2 61 fields · synced May 17, 2026
- FDA UDI db79b891-8ac3-4b41-8969-cbbe491f8030 37 fields · synced May 30, 2026
- EUDAMED 58d72136-c162-476f-8064-6079cc768437 61 fields · synced Jul 13, 2026
- EUDAMED 27a366d2-724b-442f-a234-d6f7e065b76c 61 fields · synced Oct 1, 2026