Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027510187

FEI Number

3027510187

Entity Name

CORSANO HEALTH B.V.

City/State/Country

The Hague Zuid-Holland, NL

Establishment Address

The Hague Tech Office 1.07, Waldorpstraat 5, The Hague Zuid-Holland 2521 CA, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Corsano Health B.V. (Owner Number: 10090535)

Owner / Operator Contact Address

The Hague Tech Office 1.07, Waldorpstraat 5, The Hague, NL-ZH 2521 CA, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232548

PMA Number

N/A

All Registered Proprietary Names

Charge Station 10 Sensors A Strap Silicon blue CardioWatch 287-2 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-10
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-04-10
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-04-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-04-10
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2024-04-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-04-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-10

Official Correspondent

Peter Stas

US Agent Details

Stephan Toupin Business: DAWA Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Corsano Health B.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH

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

Similar Registrations

Registration Number	Establishment Name	Location
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027510187. Last updated year: 2026. Please use registration number 3027510187 when referencing this establishment in official correspondence.