Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020659

FEI Number

3004164014

Entity Name

MEDIPLAST AB

City/State/Country

MALMO Skane, SE

Establishment Address

Bronsaldersgatan 2, MALMO Skane SE-213 76, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIPLAST AB (Owner Number: 9003376)

Owner / Operator Contact Address

Bronsaldersgatan 2, P.O. BOX 1004, MALMO, SE-NOTA 21210, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mediplast Evacuator, oral cavity Mediplast Ear Suction Mediplast Microsurgical Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	1991-05-30
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2002-09-12
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2014-04-01

Official Correspondent

JERKER KARLSSON

US Agent Details

Susan Reece Business: Invotec International Email: susanlreece@invotec.net Phone: (800) 9988580

Related Public Records

Same Entity

MEDIPLAST AB

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 8020659. Last updated year: 2026. Please use registration number 8020659 when referencing this establishment in official correspondence.