Cervicothoracic spine orthosis - UK MHRA Medical Device Registration
Cervicothoracic spine orthosis is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 126363. The device is manufactured by OPTEC USA Inc from United States, classified as General Medical Device. The authorized representative in the UK is Wellkang Ltd.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Device Type
General Medical Device
Devices
Cervicothoracic spine orthosis
Type
Class I
Date Registered
Nov 26, 2024
Last Updated
Sep 25, 2024
Name
OPTEC USA IncAddress
975 Progress Circle
Lawrenceville, Georgia, United States
Created Date
Dec 22, 2021
Name
Wellkang LtdRelationship Type
Address
Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE
Manual blood lancing device, single-use
Type: General Medical Device
Manufacturer: Tasso, Inc.
Stationary gamma camera system
Type: General Medical Device
Manufacturer: GE Medical Systems Israel Functional Imaging
Physiologic monitoring system alarm
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Bedside information system application software
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Wireless patient monitor/sensor reporting software, professional-only
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Wireless patient monitor/sensor reporting software, professional-only
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Orthopaedic implant aiming/guiding block, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Bone nail guidewire, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Multiple anaemia-related analyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Multiple urine analyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Cancer antigen 125 (CA125) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Glucose IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Fibrinogen assay (factor I) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
Multiple human hormone IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.
General specimen container IVD, no additive/medium
Type: In Vitro Diagnostic Device
Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
SARS-CoV-2/influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Manufacturer: Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Plasma protein IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: LGC Clinical Diagnostics, Inc.

