FDA Registration
Active
🇬🇧 United Kingdom
HUNTLEIGH HEALTHCARE LTD.
Reg #: 1000589001
·
FEI: 1000589001
·
Expires 2026
Products
10
Proprietary Names
30
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- HUNTLEIGH HEALTHCARE LTD.
- Registration Number
- 1000589001
- FEI Number
- 1000589001
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DIAGNOSTIC PRODUCT DIVISION, 35 PORTMANMOOR ROAD
- City
- CARDIFF, SOUTH GLAMORGAN
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K081572
Owner / Operator
- Firm Name
- ARJOHUNTLEIGH AB
- Operator Number
- 8010077
- Address
- Hans Michelsensgatan 10
- City
- Malmo
- State
- Skane
- Postal Code
- 211 20
- Country
- SE
US Agent
- Business Name
- Arjo, Inc.
- Contact Name
- Darren DeMerritt
- Address
- 2000 Center Drive, Suite D403
- City
- Hoffman Estates
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 425 3089587
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2011-03-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-02-23 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2021-09-07 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2013-02-05 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2025-02-04 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2008-03-04 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2020-01-30 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2020-01-30 |
| Monitor, Ultrasonic, Nonfetal | JAF | Class 2 | Radiology | No | 2020-01-30 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2020-01-30 |
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
Sonicaid Freedom Wireless Fetal Monitoring System
SONCAID TEAM3 ANTEPARTUM
SONCAID TEAM3 INTRAPARTUM
OBIX BeCA
Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR)
Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility