Name: Phimostop version 4.0 22 tuboids - Medical Device for the Treatment of Phimosis Validated by the Ministry of Health
SKU: 177463
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Phimostop version 4.0 22 tuboids – Medical Device for the Treatment of Phimosis Validated by the Ministry of Health

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Product Description

Treating phimosis without circumcision

PHIMOSTOP is a medical device designed to get the patient back to how they were before developing phimosis, without the need for circumcision surgery. PHIMOSTOP solves the phimosis condition without surgery by progressively dilating the phimosis ring and promoting the formation of new elastic cells that stabilise the result.

Phimostop has been validated by the Ministry of Health (BD/RDM: 1058196) and it is a medical device for the treatment of phimosis as an alternative to circumcision surgery, subject of clinical research at the Policlinico of the Tor Vergata University of Rome with publication in the international journal “Transnational Andrology and Urology” in 2021.

SAFE

Validated by the Italian Ministry of Health

Phimostop has been validated by the Ministry of Health on 13/1/2014 with the No. 1058196 and the manufacturer is Phimomed Srls.

Registration number assigned by the BD/RDM system: 1058196

CND classification: U9099 – DEVICES FOR UROGENITAL APPARATUS – OTHER

CE Class – Class I

Clinical Research Object

Subject of a clinical research of the Policlinico Tor Vergata of Rome “Can circumcision be avoided in male adults with phimosis? Results of the Phimostop prospective trial”.

The clinical research was published in the international journal “Transnational Andrology and Urology” in 2021.

EU patent

The Italian patent was filed with No. RM 2010A000632 on 06/12/2010 Subsequently granted with No. 0001406753 on 07/03/2014.

Obtained the EU patent granted with No. 2648642.

Class I medical device

Phimostop is a Class I medical device, which can be ordered without a prescription. Material tested according to current regulations:

– F.D.A. title 21 section CFR 177.2600 & BfR XV (silicone) food sector

– USP Class VI, ISO 10993 & 3A Sanitary standard medical sector

– KTW, W270, WRAS, ACS approval drinking water sector

– European Pharmacopoeia EP 3.1.9 pharmaceutical sector

– ISO 10993 test and USP Class IV test

EASY TO USE

Phimostop consists of 22 tuboids offering gradual treatment of phimosis. The single elements are specially designed to be positioned on the glans and carry out a progressive and gentle dilation directly on the part affected by the narrowing.

Tuboids can be kept in place permanently day and night or as needed. It is not necessary to remove it even for urination.

Wearing the tuboid does not limit any activity, you practically forget you are wearing it.

EFFECTIVE on different types of phimosis

Acquired Phimosis

In cases of ACQUIRED PHIMOSIS, the medical device acts on the phimotic ring, stimulating the creation of new elastic cells that will replace the inelastic ones, created by the phimotic tissue.

Congenital Phimosis

In CONGENITAL PHIMOSIS, on the other hand, the device induces the growth of the diameter of the foreskin, as a physiological response to dilation, solving the congenital problem.

PAINLESS

Phimostop has no side effects and it causes no pain.

Do not use in case of:

· Paraphimosis

· Lichen sclerus atrophicus

· Untreated lesions and/or infections

· Hypersensitivity to the material of the tuboids

Technical specifications

Tuboids 22 of progressive size, starting from 6 mm up to 42,75 mm with 1,75 mm progression Band-Aid A 5m band-aid to be applied to keep the tuboid stable Material Medical silicone Reuse Simply disinfect before use. It can be washed with soap and water Patent EU Patent 2648642 Validation Validated by the Italian Ministry of Health No. 1058196

Package Dimensions ‏ : ‎ 18.3 x 12.6 x 7.9 cm; 230 Grams
Manufacturer ‏ : ‎ Phimomed
ASIN ‏ : ‎ B09LD3L99G
Manufacturer reference ‏ : ‎ 062021
Country of origin ‏ : ‎ Italy

Subject of clinical research at the Policlinico of the University of Tor Vergata in Rome with publication in the international journal “Translational Andrology and Urology”
EU Patent (No. 2648642) with CE Marking
100% Made in Italy

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