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Disposable handle with needle electrode, 2 switches, cable 3m, SDS plug, sterile

EUDAMED

Class IIb (EU MDR)

Ref 847-S31

by Emed Sp. Z O. O. Sp. K.

Identity

Trade Name
Disposable handle with needle electrode, 2 switches, cable 3m, SDS plug, sterile EUDAMED
Device Name
ELECTRODE HANDLE, STERILE EUDAMED
Model / Reference
847-S31 EUDAMED

Identifiers

Primary DI / UDI-DI
05907763284386 EUDAMED
Basic UDI-DI
59077632-TF19HANDLE-S-YA EUDAMED
EMDN Code
K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

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 handpiece/electrode, monopolar, single-use

Disposable handle with needle electrode, 2 switches, cable 3m, SDS plug, sterile by Emed Sp. Z O. O. Sp. K. — Class IIb — MDR — listed in EUDAMED

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Emed Sp. Z O. O. Sp. K.
EUDAMED SRN
PL-MF-000012648

Sources (1)

  • EUDAMED 3454caf8-cd64-4579-92da-dd9da18a3a3c 61 fields · synced Jul 12, 2026