Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614470

FEI Number

3002663379

Entity Name

RADIOMETER BASEL AG

City/State/Country

BASEL Basel-Stadt, CH

Establishment Address

AUSTRASSE 25, BASEL Basel-Stadt 4051, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RADIOMETER MEDICAL APS (Owner Number: 8020503)

Owner / Operator Contact Address

AAKANDEVEJ 21, --, BROENSHOEJ, DK-84 2700, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TCM TOSCA Monitoring System TCM CombiM Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2016-09-02
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2016-09-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-09-02
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2016-09-02
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2016-09-02

Official Correspondent

Hsiao-Qing Chow

US Agent Details

MATT ACKERMAN Business: Radiometer America, Inc Email: mackerman@radiometeramerica.com Phone: (657) 2861022

Related Public Records

Same Entity

RADIOMETER MEDICAL APS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014506106	Radiometer Minneapolis	New Brighton, MN, US
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
1523456	RADIOMETER AMERICA, INC.	Middleburg Heights, OH, US
3007490412	Radiometer Sp. z o.o	Stargard Zachodniopomorskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K893133	Mennen Medical, Inc.	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	1989-07-14
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

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
3016701404	Philips North America LLC	Export, PA, US
3012528160	Philips North America LLC	Murrysville, PA, US
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE
8030885	PERIMED AB	JARFALLA Stockholm, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614470. Last updated year: 2026. Please use registration number 9614470 when referencing this establishment in official correspondence.