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Zmi

FDA UDI

Class II (US FDA UDI)

by ZMI Electronics Ltd.

Identity

Trade Name
ZMI FDA UDI
Generic Name
Neuromuscular transmission electrode FDA UDI
Device Name
Self-adhesive electrode package (with magnetic snap) , Black, Each package contains dia.55mm (4pcs) + 50mm*90mm (2pcs) FDA UDI
Model / Reference
SAE-MC-B-PD FDA UDI
Description
Self-adhesive electrode package (with magnetic snap) , Black, Each package contains dia.55mm (4pcs) + 50mm*90mm (2pcs) FDA UDI

Identifiers

Catalog Number
SAE-MC-B FDA UDI
Primary DI / UDI-DI
04719872330431 FDA UDI
510(k) Number
K180865 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Neuromuscular transmission electrode FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neuromuscular transmission electrode

Zmi by ZMI Electronics Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neuromuscular transmission electrode.

Cleared under the same submission

K180865 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZMI Electronics Ltd.

Sources (1)

  • FDA UDI 4d0e9d6b-a977-499a-a1c3-dd07a0207cf6 37 fields · synced Jun 8, 2026