Olsetrf04

EUDAMED

Class IIb (EU MDR)

Ref OLSETRF04Model ΣΕΤ ΗΛΕΚΤΡΟΔΙΩΝ ΡΑΔΙΟΚΥΜΑΤΩΝ ΣΠΟΝΔΥΛΙΚΗΣ ΣΤΗΛΗΣ

by Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.π.ε.

Identity

Trade Name: OLSETRF04 EUDAMED
Device Name: ΣΕΤ ΗΛΕΚΤΡΟΔΙΩΝ ΡΑΔΙΟΚΥΜΑΤΩΝ ΣΠΟΝΔΥΛΙΚΗΣ ΣΤΗΛΗΣ EUDAMED
Model / Reference: ΣΕΤ ΗΛΕΚΤΡΟΔΙΩΝ ΡΑΔΙΟΚΥΜΑΤΩΝ ΣΠΟΝΔΥΛΙΚΗΣ ΣΤΗΛΗΣ EUDAMED
OLSETRF04 EUDAMED

Identifiers

Primary DI / UDI-DI: 05213013380075 EUDAMED
Basic UDI-DI: 521301338SPINEELEC-ETGH EUDAMED
EMDN Code: K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED

Classification

Device Class: Class IIb EUDAMED
Medical Purpose: Electrosurgical Radiofrequency Electrodes EUDAMED

Clinical & Handling

Sterile

EUDAMED

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Olsetrf04 by Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.π.ε. — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS

Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
Symmetry Olsen — Olsen Medical · Class II
FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
VIVA RF electrode — STARMED CO., LTD · Class IIb
CONMED — Conmed Corporation · Class II

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	521301338SPINEELEC-ETGH	Class IIb	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.π.ε.
EUDAMED SRN: GR-PR-000020404

Sources (1)

EUDAMED 459bdca5-2993-47b8-9f88-01e0d4908abc 61 fields · synced Oct 7, 2026