Medical device makers in Tunisia: 10 FDA-registered establishments

Name: FDA-registered medical device makers in Tunisia
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

10 establishments in Tunisia are registered with the FDA to make medical devices for the US market, listing 30 device types. 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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TunisiaCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Cover, Limb	IPM	3
Sling, Arm	ILI	2
Orthosis, Lumbar	IQE	2
Joint, Knee, External Brace	ITQ	2
Electrode, Electrocardiograph	DRX	2
Orthosis, Lumbo-Sacral	IPY	2
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2
Stocking, Medical Support (For General Medical Purposes)	FQL	2
Orthosis, Limb Brace	IQI	2
Joint, Ankle, External Brace	ITW	2
Binder, Abdominal	FSD	2
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2
Set, Administration, Intravascular	FPA	1
Dispenser, Liquid Medication	KYX	1
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1
Spirometer, Therapeutic (Incentive)	BWF	1
Catheter, Retention Type, Balloon	EZL	1
Device, Cystometric, Hydraulic	FEN	1
System, Peritoneal, Automatic Delivery	FKX	1
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	1
Pump, Portable, Aspiration (Manual Or Powered)	BTA	1
Device, Transfer, Patient, Manual	FMR	1
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	1
Accessories, Blood Circuit, Hemodialysis	KOC	1
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	1
Injector, Contrast Medium, Automatic	IZQ	1
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	1
Subsystem, Water Purification	FIP	1
Tube, Smoke Removal, Endoscopic	FCZ	1

Makers in Tunisia

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	Source
Cair Tunisie	Kalaa Kebira Sousse, Tunisia	3	6	api.fda.gov
Bieffe Medital Manufacturing Oued Ellil Tunisia	Oued Ellil Manouba, Tunisia	5	4	api.fda.gov
DJO Tunisia	Sfax, Tunisia	12	2	api.fda.gov
DJO Tunisie	Sfax, Tunisia	12	2	api.fda.gov
Plastic Electromechanic Company Medical Device	Bir Mcherga Zaghouan, Tunisia	2	2	api.fda.gov
Adhe-Els International	Kalaa Kebira Sousse, Tunisia	1	0	api.fda.gov
Medica Mediterranee	Menzel Jemil Bizerte, Tunisia	1	0	api.fda.gov
Promedtech	Fouchena Tunis, Tunisia	4	0	api.fda.gov
Plastic Electromechanic Company Plus	Z.I HAMMAM-ZRIBA Zaghouan, Tunisia	2	0	api.fda.gov
Skylla SARL	Aissa Tunis, Tunisia	2	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.