HomeUnited Kingdom of Great Britain and Northern IrelandFlexicare Medical Limited.

Flexicare Medical Limited.

United Kingdom of Great Britain and Northern Ireland · Mountain Ash
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
50listed device types
Class I 34Class II 16Class III 0
plus 120 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class II 11
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
16registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
56 including historic records
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
12device registrations
CLASS B 11CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
87active ARTG entries
Class I 21IIa 48IIb 3Class Is (sterile) 15
HKHong KongMDACS
47valid listings
Class II 46Class III 1
ILIsraelAMAR
17registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States120 registration records, 15 510(k), 0 PMA, 2 excluded
Brazil11 confirmed, 1 excluded
Saudi Arabia16 confirmed, 0 excluded
Manufacturer names merged into this page: FLEXICARE MEDICAL (DONGGUAN) LTD. · FLEXICARE MEDICAL LTD. · FLEXICARE MEDICAL LIMITED · Flexicare Medical Limited
Same-named companies — This database also contains companies with near-identical names: FLEXICARE MEDICAL (DONGGUAN) LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Mountain Ash

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
FLEXICARE MEDICAL LIMITED
Company number
02428573
Registration status
Active
Legal form
Private Limited Company
Incorporated
1989-10-03
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
C/O FLEXICARE (GROUP) LIMITED, MOUNTAIN ASH, CF45 4ER

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11995
22009
12013
22014
12015
22016
12017
12018
22020
12025
12026

FDA listed device types

showing 8 of 50
Forceps 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Mask, Oxygen, Non-Rebreathing 1Clamp 1Airway, Nasopharyngeal 1System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile 1Mask, Gas, Anesthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251448FL-10000U Respiratory Humidifier2026-01-16
USK250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)2025-05-20
USK201666SINGLE USE MANOMETER2020-11-13
BR81027710002REANIMADOR MANUAL DESCARTÁVEL FLEXICAREClass II
BR81027710003REANIMADOR MANUAL REUTILIZÁVEL FLEXICAREClass II
BR80071260426BOLSAS DO RESERVATÓRIO DE SILICONEClass II
SAME0000004607SFDAA00056Parallel Pediatric/Neonatal Circuit
SAME0000004607SFDAA00055Anesthesia Face Mask Silicone Reusable

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