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Pharmaplast S.A.E.

Country not established FDA

Devices
1
Registrations
FDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Pharmaplast S.A.E. makes

Pharmaplast S.A.E. manufactures ABSOCLEAR, a medical device designed for wound irrigation and debridement, likely intended for clinical use in cleaning and preparing wounds before treatment.

The company’s portfolio is regulated under FDA 510(k) clearance as a Class II device, and the product is listed in the U.S. regulatory database. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Absoclear Ref K130553

    Active Regimes: 510(k) Registry: 510(k) Class:—

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Pharmaplast S.A.E., initiated on 2011-02-21. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2011

    • 21 Feb 2011 Z-1875-2011 Unclassified (pre-2012) Terminated The bandages are labeled as sterile, but failed sterility testing. Distribution: Nationwide Distribution - Including Illinois.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Pharmaplast S.A.E. ALEXANDRIA Al Iskandariyah · EG FEI 3003767891

Frequently asked questions

How many devices does Pharmaplast S.A.E. have in the registry?

The registry currently lists 1 device for Pharmaplast S.A.E.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pharmaplast S.A.E.'s devices?

Among its 1 most recently registered device, Pharmaplast S.A.E. has devices listed in FDA 510(k) (1 device).

Are there FDA recall records for Pharmaplast S.A.E.?

FDA recall records list 1 recall initiated by Pharmaplast S.A.E., the most recent initiated on 21 Feb 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Pharmaplast S.A.E. in the registry?

The most recently registered devices listed for Pharmaplast S.A.E. include ABSOCLEAR.

Which FDA establishments are linked to Pharmaplast S.A.E.?

1 FDA establishment is linked to Pharmaplast S.A.E. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.