Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006807694

FEI Number

3006807694

Entity Name

USR ELECTRONIC SYSTEMS (1987) LTD

City/State/Country

Karmiel Northern, IL

Establishment Address

19 Napach Street, Industrial Park, Karmiel Northern 21617, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

USR Electronic Systems (1987) Ltd (Owner Number: 10044382)

Owner / Operator Contact Address

19 Napach Street, Industrial Park, Karmiel, IL-NOTA 21617, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N85, Microcap Plus DS Applicator Polaris WR SR Applicator ST Applicator AC Applicator Pitanga ST Applicator AC Applicator SR Applicator SRA Applicator DS Applicator Ventway Sparrow Microcap Motif LHR Applicator LVA Applicator Sublative RE Applicator DSL Applicator Sublime Applicator DS Applicator AC Applicator WRA Applicator SRA Applicator LV Applicator SR Applicator MASSAGER, VACUUM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-06-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-06-03
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2018-03-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-03-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2026-03-06
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-06-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-03-28
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2018-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

USR Electronic Systems (1987) Ltd

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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006807694. Last updated year: 2026. Please use registration number 3006807694 when referencing this establishment in official correspondence.