Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617268

FEI Number

1000352675

Entity Name

Honeywell Healthcare Solutions GmbH (formerly EnviteC)

City/State/Country

WISMAR Mecklenburg-Western Pomerania, DE

Establishment Address

ALTER HOLZHAFEN 18, WISMAR Mecklenburg-Western Pomerania 23966, DE

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Honeywell Healthcare Solutions GmbH (formerly EnviteC) (Owner Number: 10060527)

Owner / Operator Contact Address

Alter Holzhafen 18, Wismar, DE-MV 23966, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MySign O Oxygen Measuring Device AlcoQuant 6020 Plus Flow Sensor SpiroQuant H Flow Sensor SpiroQuant A+ Flow Sensor SpiroQuant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2019-05-23
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2019-05-23
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2019-05-23

Official Correspondent

Stefan Miska

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

Honeywell Healthcare Solutions GmbH (formerly EnviteC)

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
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
2026424	Teledyne Analytical Instruments	City Industry, CA, US
9613449	IT DR. GAMBERT GMBH	WISMAR Mecklenburg-Western Pomerania, DE
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3004415070	KB Components Finland Oy	Nurmijarvi Etela-Karjala, FI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617268. Last updated year: 2026. Please use registration number 9617268 when referencing this establishment in official correspondence.