← Back to catalogue
Turtle Gun
EUDAMEDClass IIb (EU MDR)
Ref SW-FS-08Ref SW-FS-11Ref SW-FS-06Ref SW-FS-05Ref SW-FS-01Ref SW-FS-12Ref SW-FS-04Ref SW-FS-10Ref SW-FS-03
Identity
- Trade Name
- Turtle Gun EUDAMED
- Device Name
- ABRO & Turtle Gun EUDAMED
- Model / Reference
- SW-FS-08 EUDAMEDSW-FS-11 EUDAMEDSW-FS-06 EUDAMEDSW-FS-05 EUDAMEDSW-FS-01 EUDAMEDSW-FS-12 EUDAMEDSW-FS-04 EUDAMEDSW-FS-10 EUDAMEDSW-FS-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563433 EUDAMED08809272564188 EUDAMED08809272562719 EUDAMED08809272562702 EUDAMED08809272562610 EUDAMED08809272564195 EUDAMED08809272562696 EUDAMED08809272564171 EUDAMED08809272562689 EUDAMED
- Basic UDI-DI
- B-08809272563433 EUDAMEDB-08809272564188 EUDAMEDB-08809272562719 EUDAMEDB-08809272562702 EUDAMEDB-08809272562610 EUDAMEDB-08809272564195 EUDAMEDB-08809272562696 EUDAMEDB-08809272564171 EUDAMEDB-08809272562689 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Turtle Gun by Seawon Meditech Co., Ltd. — Class IIb — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809272563433 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED fcc58063-a329-4181-a9b2-ea5826733b28 61 fields · synced Sep 30, 2026
- EUDAMED 5c999682-4ca8-4d10-bdd2-c2168cdd9c2c 61 fields · synced May 16, 2026
- EUDAMED f18d5a71-7e8b-4a1e-a21c-65911518c1a1 61 fields · synced May 17, 2026
- EUDAMED 6645e984-d69f-4b32-b055-15c9f7597c26 61 fields · synced May 17, 2026
- EUDAMED 55cf0905-3ec4-4428-abb5-fe72171f164f 61 fields · synced May 17, 2026
- EUDAMED 0b8a2ced-0849-43f4-88fb-952a1f44b73b 61 fields · synced May 17, 2026
- EUDAMED 1755e51d-f78e-4c9e-b794-d1c6f2904683 61 fields · synced May 17, 2026
- EUDAMED 5bb62d5c-a834-447e-8fb3-5f1e25d24ba8 61 fields · synced May 18, 2026
- EUDAMED e122e741-eb58-4608-ae26-235f8cf35006 61 fields · synced May 19, 2026