Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000589001

FEI Number

1000589001

Entity Name

HUNTLEIGH HEALTHCARE LTD.

City/State/Country

CARDIFF, SOUTH GLAMORGAN, GB

Establishment Address

DIAGNOSTIC PRODUCT DIVISION, 35 PORTMANMOOR ROAD, CARDIFF, SOUTH GLAMORGAN CF24 5HN, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARJOHUNTLEIGH AB (Owner Number: 8010077)

Owner / Operator Contact Address

Hans Michelsensgatan 10, Malmo, SE-M 211 20, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250777

PMA Number

N/A

All Registered Proprietary Names

MP1R MINI PULSE MP1 Disposable Intraoperative Probe (DIOP8) WoundExpress Garment WoundExpress Pump DOPPLEX ABILITY HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) Sonicaid Team 3 Centrale Dopplex D930 VP10 VP5 FD3, OBSTETRIC DOPPLER OP2 VP8 DMX HANDHELD DOPPLER AND PROBES SRX HANDHELD DOPPLER AND PROBES FETAL DOPPLEX, FD1 VP4 OP3 Team3 Fetal Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-03-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-02-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-09-07
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2013-02-05
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-05
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2025-02-04
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2007-12-19
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2008-03-04
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2020-01-30
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2020-01-30
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2020-01-30
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2020-01-30
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2020-01-30
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-01-30
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2008-03-04
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2008-03-04
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2025-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Darren DeMerritt Business: Arjo, Inc. Email: darren.demerritt@arjo.com Phone: (425) 3089587

Related Public Records

Same Entity

ARJOHUNTLEIGH 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
3002806395	ARJOHUNTLEIGH AB	MALMO Skane, SE
9681684	ARJOHUNTLEIGH MAGOG, INC.	MAGOG Quebec, CA
3005619970	Arjo (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3007420694	ArjoHuntleigh Polska Sp. zo.o.	Poznan Wielkopolskie, PL

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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1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
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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 1000589001. Last updated year: 2026. Please use registration number 1000589001 when referencing this establishment in official correspondence.