Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610639

FEI Number

3002806708

Entity Name

CLEMENT CLARKE INTL., LTD.

City/State/Country

Mountain Ash Rhondda Cynon Taff, GB

Establishment Address

Cynon Valley, Business Park, Mountain Ash Rhondda Cynon Taff CF45 4ER, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

FLEXICARE MEDICAL LTD. (Owner Number: 8021995)

Owner / Operator Contact Address

CYNON VALLEY BUSINESS PARK, MOUNTAIN ASH, GB-RCT CF45 4ER, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K980960

PMA Number

N/A

All Registered Proprietary Names

FLEXICARE SILICONE ANAESTHETIC FACE MASKS FLEXICARE ANAESTHETIC MASKS SootherMask InspiraMask InspiraChamber, VentiChamber MWPFM L/R ATS ATM SINGLE MWPFM AFSLOW RANGE ATS MW AFS ATS (MEDLINE) 12X30 BOX Flutter IN-CHECK ORAL ATM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2007-01-17
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2023-10-12
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2023-07-24
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2023-07-24
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2023-07-24

Official Correspondent

Rebecca Funston

US Agent Details

ASHLEY MOTAMEDI Email: ashley.motamedi@flexicare.com Phone: (949) 4509999

Related Public Records

Same Entity

FLEXICARE MEDICAL LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB
3006061749	FLEXICARE MEDICAL (DONGGUAN) LTD.	DONGGUAN CITY Guangdong, CN
3017202422	Flexicare Lanka (Pvt) Ltd	Bandaragama Western, LK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17

Similar Registrations

Registration Number	Establishment Name	Location
3010362947	Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, CN
2028807	WESTMED, INC.	TUCSON, AZ, US
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3005977696	MEDICAL DEVELOPMENTS INTERNATIONAL	Scoresby Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610639. Last updated year: 2026. Please use registration number 9610639 when referencing this establishment in official correspondence.