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limb clamp ecg electrodes

EUDAMED

Class I (EU MDR)

Ref AMD-LE-AB0001-IModel AMD-SE/LE

by Shenzhen Amydi-med Electrics Tech Co., Ltd

Identity

Trade Name
limb clamp ecg electrodes EUDAMED
Device Name
ECG electrodes EUDAMED
Model / Reference
AMD-SE/LE EUDAMED
AMD-LE-AB0001-I EUDAMED

Identifiers

Primary DI / UDI-DI
06931377230919 EUDAMED
Basic UDI-DI
69313772807UW EUDAMED
EMDN Code
Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Denmark EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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: General-purpose multi-parameter bedside monitor

limb clamp ecg electrodes by Shenzhen Amydi-med Electrics Tech Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000013201
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 7d00ff40-1d25-4eca-b3d6-984c2fffa205 61 fields · synced Jun 18, 2026