Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010877292

FEI Number

3010877292

Entity Name

PHARMA SYSTEMS EESTI OU

City/State/Country

Riidakula Hiiumaa, EE

Establishment Address

Parma, Riidakula Hiiumaa 92020, EE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pharma Systems Eesti OU (Owner Number: 10048263)

Owner / Operator Contact Address

parma, Riidakula, EE-39 92020, EE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K903056

PMA Number

N/A

All Registered Proprietary Names

Pharma Neo Pharma Neo Port Pharma Trach Multi-Function Pharma Trach Item Pharma Trach Basic Pharma Suction

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	2014-12-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-12-22

Official Correspondent

david rothkopf

US Agent Details

David Rothkopf Business: MEDicept Inc Email: Drothkopf@medicept.com Phone: (617) 8993448

Related Public Records

Same Entity

Pharma Systems Eesti OU

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 3010877292. Last updated year: 2026. Please use registration number 3010877292 when referencing this establishment in official correspondence.