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Extended Ball Electrode, 4mmø x 113mm
EUDAMEDClass IIb (EU MDR)
Ref PS5004Model TF-1040
Identity
- Trade Name
- Extended Ball Electrode, 4mmø x 113mm EUDAMED
- Device Name
- Ball Electrode EUDAMED
- Model / Reference
- TF-1040 EUDAMEDPS5004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223005254 EUDAMED
- Basic UDI-DI
- B-05051223005254 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Extended Ball Electrode, 4mmø x 113mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…
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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-05051223005254 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED cdd8dd4f-0333-4694-be6f-5cf0e9e54058 61 fields · synced Jun 19, 2026