MediMax Tech

FDA UDI

Class II (US FDA UDI)

by Medimax Tech Inc.

Identity

Trade Name: MediMax Tech FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: BH2527P Needle Electrodes - Hypodermic Needle, Prewired, 25mm Length, 0.40mm(27G) Diameter. FDA UDI
Model / Reference: BH2527P Needle Electrodes FDA UDI
Description: BH2527P Needle Electrodes - Hypodermic Needle, Prewired, 25mm Length, 0.40mm(27G) Diameter. FDA UDI

Identifiers

Primary DI / UDI-DI: 00817325020251 FDA UDI
FDA Product Code: IKT FDA UDI
GXZ FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1385 FDA UDI
882.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromyographic needle electrode, single-use

MediMax Tech by Medimax Tech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medimax Tech Inc.

Sources (1)

FDA UDI 21f536ef-d600-44d5-9ee7-524771ba4331 34 fields · synced Jun 8, 2026