Identity
- Trade Name
- ELRA electrode EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- ELRA electrode EUDAMEDThe ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. FDA UDI
- Model / Reference
- 7-2B22S EUDAMEDFDA UDI
- Description
- The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306762368 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809306762368 EUDAMED880930676ELRA_EPM EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- France EUDAMEDBulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Shaft Length — 40 Centimeter FDA UDI
ELRA electrode by Starmed Co., Ltd — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306762368 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306762368 | 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 (3)
- EUDAMED b4966c25-f55b-4595-9add-cf2e004f022e 61 fields · synced Jul 10, 2026
- EUDAMED 639264d6-9e24-4d2a-938b-08a14d06a6ca 61 fields · synced May 18, 2026
- FDA UDI 03a59b4f-8ba7-4311-acff-7d4069464a67 36 fields · synced May 30, 2026