Bodyotics Dilator Exerciser Set

Organization name

eBrands Global Oy

SRN

FI-MF-000049374

Manufacturer status

Active

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• CW999

  Warnings • For personal use only. Do not share with others. • Use only as instructed by a medical professional or as described in these IFUs. • Discontinue use and consult a professional if you experience bleeding, pain, or unusual discomfort. Precautions • Always wash hands before handling the device. • Inspect each dilator before use; do not use if damaged or degraded. • Use a water-based lubricant if needed. • Start with the smallest size, increasing only when comfortable.

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Trade name

Bodyotics Dilator Exerciser Set

UDI-DI code

00810103870680

Basic UDI-DI

081010387DILSET01DB

Reference / catalog number

EB-BO-006

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The device is a non-active, non-sterile, reusable vaginal dilator made of medical-grade silicone. It is intended for self-insertion by the patient into the vaginal canal as part of pelvic floor therapy or dilation treatment under medical recommendation. The dilator is used to progressively stretch the vaginal tissue, typically to address conditions such as vaginismus, vaginal stenosis, or dyspareunia. After each use, the device is cleaned and reused by the patient. Intended for transient use (< 60 minutes per use session)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• L0509020101VAGINAL DILATORS, REUSABLE

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