Data / Medical devices / Egypt / Pharmaplast S.A.E.

Pharmaplast S.A.E.: FDA-registered device maker in ALEXANDRIA Al Iskandariyah, Egypt, 1 510(k) clearance

Name: Pharmaplast S.A.E. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pharmaplast S.A.E. is registered with the FDA (registration 3003767891) in ALEXANDRIA Al Iskandariyah, Egypt. It lists 24 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 3, 2013. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003767891
Address: AMRIA free zone, ALEXANDRIA Al Iskandariyah, Egypt, 23512
Owner or operator: PHARMAPLAST S.A.E. (9035202)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: September 20, 2006
Registered through: 2027
Brand names listed: Abosclear Comfort, Absoclear, Absoclear IV Dressing, Airoplast, All wound dressing, Aluburn, Cavicoll, Cavidagel Burn Dressings and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive Backed Thermal Skin Patches	OMW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Appliance, Colostomy, Disposable	EZS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bag, Urinary, Ileostomy	EXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bag, Urine Collecting, Ureterostomy	EXG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Cast	ITG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dilator, Nasal	LWF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Contract manufacturer	accessdata.fda.gov
Nursing Pad, Hydrogel	NTC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Strip, Adhesive, Closure, Skin	FPX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 3, 2013	K130553	ABSOCLEAR	FRO	Substantially Equivalent	Pharmaplast S.A.E.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 21, 2011	58051	Not yet classified	Terminated	CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Dri	The bandages are labeled as sterile, but failed sterility testing.	accessdata.fda.gov

Compare with other makers

Updated July 3, 2013. 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.