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Disposable smoke evacuation handle with knife electrode, 2 switches, cable 3m, …

EUDAMED

Class IIb (EU MDR)

Ref 848-030

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

Identity

Trade Name
Disposable smoke evacuation handle with knife electrode, 2 switches, cable 3m, 3-pin plug, sterile. EUDAMED
Device Name
ELECTRODE HANDLE, WITH SMOKE EVACUATION FUNCTION, STERILE EUDAMED
Model / Reference
848-030 EUDAMED

Identifiers

Primary DI / UDI-DI
05907763284461 EUDAMED
Basic UDI-DI
59077632-TF19HANDLE-SE-XP 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 smoke evacuation handle with knife electrode, 2 switches, cable 3m, … 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 1a2a8a9a-6b19-4378-94d8-8efac7a1aeac 61 fields · synced Jul 28, 2026