← Back to catalogue
Intimina KegelSmart - ML2 (EN +3 more)
FDA UDIClass II (US FDA UDI)
by Leloi AB
Identity
- Trade Name
- Intimina KegelSmart - ML2(EN/IT/SV/FI) FDA UDI
- Generic Name
- Perineometer FDA UDI
- Device Name
- A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction. FDA UDI
- Model / Reference
- 0035 FDA UDI
- Description
- A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350075020032 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Perineometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Perineometer
Intimina KegelSmart - ML2 (EN +3 more) by Leloi AB — Class II — FDA UDI — listed in FDA GUDID — 4 models — regulatory data on deviCERTS
Similar devices
Also classified as Perineometer.
- Leva Pelvic Health System — AXENA HEALTH, INC. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Flyte In-Home Pelvic Floor Treatment — Pelvital USA, Inc. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- Pathway® — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- IVS-2 — PERSONAL MEDICAL CORP. · Class II
- Wellness — Blush Novelties · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leloi AB
Sources (1)
- FDA UDI 7f23b792-f244-4ecd-bb13-37910c2058d8 33 fields · synced May 30, 2026