Identity

Trade Name
Ball Electrode, 3mmø x 113mm EUDAMED
Device Name
Ball Electrode EUDAMED
Model / Reference
TF-1040 EUDAMED
PS9170 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223025016 EUDAMED
Basic UDI-DI
B-05051223025016 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

Ball Electrode, 3mmø x 113mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 7aadde5d-85bf-4bc1-8238-c39cd9e78c6c 61 fields · synced Oct 6, 2026