Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009754460

FEI Number

3009754460

Entity Name

SEEBREATH AB

City/State/Country

Stockholm, SE

Establishment Address

Birger Jarlsgatan 2, Stockholm 11434, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SeeBreath AB (Owner Number: 10041602)

Owner / Operator Contact Address

Birger Jarlsgatan 2, Stockholm, SE-AB 11434, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112840

PMA Number

N/A

All Registered Proprietary Names

CapnoDura Combi, CapnoDura Pedi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-08-10

Official Correspondent

Anette Sjogren

US Agent Details

Mark Swanson Business: QRx Partners Email: mark.swanson@qrxpartners.com Phone: (833) 7797278

Related Public Records

Same Entity

SeeBreath AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006307105	MedDev Manufacturing Sdn Bhd	Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006307105	MedDev Manufacturing Sdn Bhd	Klang Selangor, MY
3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
3010427901	CMI Health, Inc.	Alpharetta, GA, US
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009754460. Last updated year: 2026. Please use registration number 3009754460 when referencing this establishment in official correspondence.