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Disposable neutral electrode EMED SAFE, hydrogel, split, for adults and childre…

EUDAMED

Class IIb (EU MDR)

Ref 812-85H

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

Identity

Trade Name
Disposable neutral electrode EMED SAFE, hydrogel, split, for adults and children, 176x122mm, 110cm2, with 3m USA cable EUDAMED
Device Name
NEUTRAL ELECTRODE, DISPOSABLE EUDAMED
Model / Reference
812-85H EUDAMED

Identifiers

Primary DI / UDI-DI
05907763203257 EUDAMED
Basic UDI-DI
59077632-TF11NE-DISPO-MP EUDAMED
EMDN Code
K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

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: Electrosurgical return electrode, single-use

Disposable neutral electrode EMED SAFE, hydrogel, split, for adults and childre… by Emed Sp. Z O. O. Sp. K. — Class IIb — MDR — listed in EUDAMED

Similar devices

Also classified as Electrosurgical return electrode, 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 4c39ef11-2e1b-4d71-a40d-92920a981e1c 61 fields · synced Jun 19, 2026