Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022114800

FEI Number

3022114800

Entity Name

KAMEX INTERNATIONAL S.A.S

City/State/Country

Cajica Cundinamarca, CO

Establishment Address

Carrera 8E No.6-10, Cajica Cundinamarca 11001000, CO

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor

Owner / Operator

Kamex International S.A.S (Owner Number: 10084653)

Owner / Operator Contact Address

Carrera 8E No.6-10, Cajica, CO-CUN 11001000, CO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hernia Belt Kamex International Kamex International UNIVERSAL WRIST BRACE AND PLUS RIGHT AND LEFT RIGHT AND LEFT THUMB SPLINT WRISTBAND S/M, L/XL ZIMMERS SPLINT NEOPRENE WRISTBAND S, M, L, Ostomy girdle CAMP TYPE LUMBO-SACRAL BELT Closed Patella KNee Support TENNIS ELBOW WITH GEL PAD, TENNIS ELBOW Toe spacer, METATARSAL GEL PAD Dorso- Lumbar Girdle Posture Corrector-Back Brace Kamex International UNIVERSAL ANKLET Kamex International ADULT, CHILDREN AND PEDIATRIC BLACK SINGLE SLING IMMOBILIZER Sling SHOULDER BAND ADULT AND CHILDREN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2024-09-04
ISL	Joint, Hip, External Limb Component	Physical Medicine	Class 1	890.3420	2022-03-17
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-03-17
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2023-01-04
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-07-29
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-01-04
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-12-27
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2024-07-29
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2022-03-17
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2022-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Kamex International S.A.S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022114800. Last updated year: 2026. Please use registration number 3022114800 when referencing this establishment in official correspondence.