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Male Remeex System - Readjustment kit

FDA UDI

Class II (US FDA UDI)

by Desarrollo E Investigacion Medica Aragonesa Sl

Identity

Trade Name
Male Remeex System - Readjustment kit FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Model / Reference
AR-01P FDA UDI

Identifiers

Primary DI / UDI-DI
08437007606232 FDA UDI
FDA Product Code
OTM FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use 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

No

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: Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Male Remeex System - Readjustment kit by Desarrollo E Investigacion Medica Aragonesa Sl — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use.

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 6da165a8-fd65-41cc-ba93-3579789421eb 32 fields · synced Jun 8, 2026