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Permablate

FDA UDI

Class I (US FDA UDI)

by Gmmi Sdn. Bhd.

Identity

Trade Name
Permablate FDA UDI
Generic Name
Hair-removal electrolysis system needle electrode, single-use FDA UDI
Device Name
Permablate Electrolysis Unit FDA UDI
Model / Reference
PEU-K01 FDA UDI
Description
Permablate Electrolysis Unit FDA UDI

Identifiers

Catalog Number
PEU-K01 FDA UDI
Primary DI / UDI-DI
00860004198826 FDA UDI
FDA Product Code
HPY FDA UDI
GMDN Term
Hair-removal electrolysis system needle electrode, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hair-removal electrolysis system needle electrode, single-use

Permablate by Gmmi Sdn. Bhd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair-removal electrolysis system needle electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gmmi Sdn. Bhd.

Sources (1)

  • FDA UDI 7515164c-a426-47ca-ac3c-d7496cdd79d0 35 fields · synced May 30, 2026