Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011971979

FEI Number

3011971979

Entity Name

HAMILTON CENTRAL EUROPE

City/State/Country

Giarmata Timis, RO

Establishment Address

Hamilton Street No 2-4, Giarmata Timis 307210, RO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hamilton Central Europe (Owner Number: 10053968)

Owner / Operator Contact Address

Hamilton Street No 2-4, Giarmata, RO-TM 307210, RO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Breathing circuit sets, dual limb, single use, neonatal PN 260180, PN 260182, PN 260169, PN 260170 Breathing circuit sets, dual limb, single use, neonatal/pediatric PN 260241, PN 260244 HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2017-01-27
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-10-13

Official Correspondent

Elena Patrut

US Agent Details

Sachin Thanawala Business: Hamilton Medical, Inc. Email: Sachin.Thanawala@hamiltonmedical.com Phone: (775) 5165558

Related Public Records

Same Entity

Hamilton Central Europe

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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3027221819	MAGNAMED MEDICAL TECHNOLOGY	Fort Lauderdale, FL, US
3014766741	Hamilton Medical AG	Domat / Ems Graubunden, CH
3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011971979. Last updated year: 2026. Please use registration number 3011971979 when referencing this establishment in official correspondence.