← Back to catalogue
Surgical electrode
EUDAMEDClass IIb (EU MDR)
Ref Q6010AModel Surgical electrodeRef Q6201S1Ref Q6020HRef Q6201Ref Q6010HRef Q6303Ref Q6020ARef Q6301S1
Identity
- Device Name
- Surgical electrode EUDAMED
- Model / Reference
- Surgical electrode EUDAMEDQ6010A EUDAMEDQ6201S1 EUDAMEDQ6020H EUDAMEDQ6201 EUDAMEDQ6010H EUDAMEDQ6303 EUDAMEDQ6020A EUDAMEDQ6301S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244212549 EUDAMED06971244212570 EUDAMED06971244212617 EUDAMED06971244210446 EUDAMED06971244212624 EUDAMED06971244212525 EUDAMED06971244212532 EUDAMED06971244212587 EUDAMED
- Basic UDI-DI
- 697124421DJXT0001V8 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Surgical electrode by Shenyang Shenda Endoscope Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- 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 | 697124421DJXT0001V8 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenyang Shenda Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030478
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (8)
- EUDAMED a41dfb86-0c6b-46fa-ac8a-dbbefd9deb21 61 fields · synced Oct 6, 2026
- EUDAMED e853a325-9271-4914-99a4-482b163b1528 61 fields · synced May 17, 2026
- EUDAMED 1bbe1671-bafc-490c-bcec-04edb8bcb663 61 fields · synced May 17, 2026
- EUDAMED 9a9f71e4-9c46-41c4-b37a-2d7f81fcda89 61 fields · synced May 17, 2026
- EUDAMED 6c9e3de8-c427-4565-b6a1-f3ad15315593 61 fields · synced May 17, 2026
- EUDAMED 53aba85b-3a20-4743-a342-f32035e7632e 61 fields · synced May 17, 2026
- EUDAMED 5b2e143b-f47c-48ac-84e9-226cdc4146eb 61 fields · synced May 18, 2026
- EUDAMED 14ef52bb-ffad-4a5e-bfb8-f869d7c9d0ad 61 fields · synced May 18, 2026