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Remeex System (for Female Urinary Incontinence)

FDA UDI

Class II (US FDA UDI)

by Desarrollo E Investigacion Medica Aragonesa Sl

Identity

Trade Name
Remeex System (for Female Urinary Incontinence) FDA UDI
Generic Name
Urethral sphincter prosthesis, non-powered FDA UDI
Model / Reference
SREM-01 FDA UDI

Identifiers

Primary DI / UDI-DI
08437007606027 FDA UDI
FDA Product Code
OTN FDA UDI
GMDN Term
Urethral sphincter prosthesis, non-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urethral sphincter prosthesis, non-powered

Remeex System (for Female Urinary Incontinence) by Desarrollo E Investigacion Medica Aragonesa Sl — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Urethral sphincter prosthesis, non-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Desarrollo E Investigacion Medica Aragonesa Sl

Sources (1)

  • FDA UDI 57289fbb-9ed8-41a0-9ec0-543025b6fdb2 32 fields · synced May 30, 2026