Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005519819

FEI Number

3005519819

Entity Name

PHARMA SYSTEMS AB

City/State/Country

Lysekil Halland, SE

Establishment Address

Datavagen 5, Lysekil Halland SE-453 38, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pharma Systems AB (Owner Number: 10036898)

Owner / Operator Contact Address

Datavagen 5, lyekil, SE-N SE-453 38, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K903054

PMA Number

N/A

All Registered Proprietary Names

Pharma Neo Port Pharma Neo Pharma Trach Multi-Function Pharma Trach Item Pharma Trach Basic Bact-Trap Mini Bact Trap Midi Bact-HME Midi Bact-HME Pharma Mini Port Angle Pharma Mini Port Elbow Pharma Mini Port Bact-HME Port Bact-Trap Pharma Mini Pharma Suction HME 12 HME 10 HME 11 MDI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-06-06
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-01-27
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2011-06-06
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-06-06

Official Correspondent

David Rothkopf

US Agent Details

David Rothkopf Business: MEDIcept Email: drothkopf@medicept.com Phone: (617) 8993449

Related Public Records

Same Entity

Pharma Systems AB

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005519819. Last updated year: 2026. Please use registration number 3005519819 when referencing this establishment in official correspondence.