Manufacturer of medical devices specializing in Respiratory management, Respiratory, and Urology

Flexicare (Group) Limited

Mountain Ash (UK) · Lake Forest, CA (USA)New on Amplifa

1989Founded

15+Global subsidiaries

100+Countries served

About Flexicare

Flexicare is a global medical technology company based in Mountain Ash, Wales (Great Britain). The company develops, manufactures, and distributes medical devices in the three product areas: Respiratory, Airway Management, and Urology, supporting clinicians in intensive care, anesthesia, and respiratory therapy. Founded in 1989, Flexicare is active through a network of more than 15 subsidiaries and supplies healthcare facilities in over 100 countries. In addition to product development, the company offers clinical support services, training, as well as customer service and logistics for the UK, EU, and the rest of the world. Flexicare is a supplier to the NHS Supply Chain and holds certifications according to ISO 13485 and ISO 9001, along with registrations with US FDA, Health Canada, and the Japanese PMDA.

Site: CF45 4ER Mountain Ash, United Kingdom
Processes: Design, manufacture, and distribute medical devices (Airway management, Respiratory, Urology), Design, manufacturing, and distribution of medical devices, Clinical support articles/training, Customer service and logistics (UK, EU, Rest of World)
Certificates: ISO 9001, ISO 13485, MDSAP, ISO 14001 (Environmental Management, Implementation), LSAS Level 2 (Labour Standards Assurance System, NHS Supply Chain), US FDA Registration, Health Canada Registration, PMDA Registration (Japan), EU Directive 93/42/EEC (Medical Devices), PMDA (Japan), EU Directive 93/42/EEC, LSAS Level 2 (NHS Supply Chain)
Founded: 1989
Industries: Medical Technology, Intensive Care, Anesthesia, Respiratory Therapy, Urology, Healthcare/Medical Technology

01
Medical device design and development
02
Manufacturing
03
Distribution
04
Customer Service and Logistics

Locations

Mountain Ash

Head Office (Cynon Valley Business Park)

Lake Forest, CA

Flexicare, Inc. (USA)

Industries

Medical TechnologyIntensive CareAnesthesiaRespiratory TherapyUrologyHealthcare/Medical TechnologyClinical Fields: Intensive Care

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Design, manufacture, and distribute medical devices (Airway management, Respiratory, Urology)Assembly	–	–	–	–	–

Additional services

Design, manufacturing, and distribution of medical devicesClinical support articles/trainingCustomer service and logistics (UK, EU, Rest of World)

Reference customers

NHS Supply Chain (Supplier relationship, LSAS Level 2)

Quality and Certifications

Flexicare Medical Limited complies with the ISO 13485 and ISO 9001 quality standards, as well as EU Directive 93/42/EEC, and is registered with US FDA, Health Canada, and the Japanese PMDA, and is MDSAP certified. As a supplier to the NHS Supply Chain, the company holds LSAS Level 2 accreditation and is audited annually by SGS United Kingdom Limited.

Evidence	Mountain Ash
ISO 9001
ISO 13485
MDSAP
US FDA Registration
Health Canada Registration
PMDA (Japan)
EU Directive 93/42/EEC
LSAS Level 2 (NHS Supply Chain)

History

1989
Founding of Flexicare with the aim of providing reliable, precise products for clinicians