← Back to catalogue
Electrosurgical Handswitch Operated Pencil
EUDAMEDClass IIb (EU MDR)
Ref PS5555NSModel TF-1040Ref PS5557
Identity
- Trade Name
- Electrosurgical Handswitch Operated Pencil EUDAMED
- Device Name
- Electrosurgical Pencil EUDAMED
- Model / Reference
- TF-1040 EUDAMEDPS5555NS EUDAMEDPS5557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223024545 EUDAMED05051223025818 EUDAMED
- Basic UDI-DI
- B-05051223024545 EUDAMEDB-05051223025818 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Electrosurgical Handswitch Operated Pencil by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited…
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-05051223024545 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e56a6ce5-8546-4dd7-bf76-8afc5c2fff88 61 fields · synced Oct 7, 2026
- EUDAMED 0400aaf5-f72b-48bd-8f69-754ff7b86797 61 fields · synced May 18, 2026