Minitouch 3.8 Era System
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- Minitouch EUDAMEDMinitouch 3.8 Era System (Minitouch System) FDA PMA
- Generic Name
- Device, thermal ablation, endometrial FDA PMA
- Device Name
- Minitouch Generator EUDAMED
- Model / Reference
- 100001-01 EUDAMED10001-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850044503308 EUDAMED
- Basic UDI-DI
- B-00850044503308 EUDAMED
- PMA Number
- P230002 FDA PMA
- FDA Product Code
- MNB FDA PMA
- EMDN Code
- Z12080201 ENDOMETRIAL ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA PMA
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Minitouch 3.8 Era System is a thermal ablation device designed for the treatment of menorrhagia, or heavy menstrual bleeding, caused by benign conditions. It functions by performing ablation of the endometrial lining of the uterus in premenopausal women who have completed their childbearing.
This system is manufactured by Microcube, LLC and has received FDA PMA and MDD authorization. It is intended for clinical use in patients for whom childbearing is complete and who suffer from heavy menstrual bleeding due to benign causes.
Frequently asked questions
What is the Minitouch 3.8 Era System used for?
The system is indicated for the thermal ablation of the endometrial lining of the uterus to treat menorrhagia, which is heavy menstrual bleeding, in premenopausal women who have completed their childbearing.
Who is the manufacturer of this device?
The Minitouch 3.8 Era System is manufactured by Microcube, LLC, based in Fremont, California.
Is this device authorized for use?
Yes, the device has received FDA PMA and MDD authorization for its indicated use in treating heavy menstrual bleeding due to benign causes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Minitouch 3.8 Era System – P230002 - FDA, Premarket Approval (PMA) - FDA, Endometrial Ablation Devices Market Summary - DelveInsight, Microcube, LLC 4501 Minitouch - RevMed, Minitouch Handpiece 3.8 Era Minitouch 3.8 Era… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P230002 | Class III | Active |
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Manufacturer
- Manufacturer
- Microcube, LLC
Sources (2)
- FDA PMA P230002 24 fields · synced Sep 18, 2026
- EUDAMED 11bc9a1c-4ce4-4723-9e8d-4d2928653418 61 fields · synced Aug 3, 2026