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EndyMed Intensif 10 Tips Package

FDA UDI

Class II (US FDA UDI)

by Endymed Medical Ltd

Identity

Trade Name
EndyMed Intensif 10 Tips Package FDA UDI
Generic Name
Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
Device Name
Tips that are used with the intensif handpiece (1st generation). FDA UDI
Model / Reference
Intensif 10 Tips Package FDA UDI
Description
Tips that are used with the intensif handpiece (1st generation). FDA UDI

Identifiers

Catalog Number
ND_PRD00045 FDA UDI
Primary DI / UDI-DI
07290016814323 FDA UDI
510(k) Number
K130501 FDA UDI
FDA Product Code
GEI FDA UDI
OUH FDA UDI
GMDN Term
Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cosmetic micro-needling electronic handpiece cartridge, professional

EndyMed Intensif 10 Tips Package by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic micro-needling electronic handpiece cartridge, professional.

Cleared under the same submission

K130501 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endymed Medical Ltd

Sources (1)

  • FDA UDI 3936b940-6957-4669-b3bd-c0914c8f8513 36 fields · synced May 30, 2026