FDA Registration
Active
🇬🇧 United Kingdom
CLEMENT CLARKE INTL., LTD.
Reg #: 9610639
·
FEI: 3002806708
·
Expires 2026
Products
5
Proprietary Names
26
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- CLEMENT CLARKE INTL., LTD.
- Registration Number
- 9610639
- FEI Number
- 3002806708
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Cynon Valley, Business Park
- City
- Mountain Ash Rhondda Cynon Taff
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K130598
Owner / Operator
- Firm Name
- FLEXICARE MEDICAL LTD.
- Operator Number
- 8021995
- Address
- CYNON VALLEY BUSINESS PARK
- City
- MOUNTAIN ASH
- State
- Rhondda Cynon Taff
- Postal Code
- CF45 4ER
- Country
- GB
- Correspondent
- Rebecca - Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2007-01-17 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2023-10-12 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2023-07-24 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2023-07-24 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2007-01-18 |
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
FLEXICARE MOUTHPIECE
ONE WAY VALVE EXP(200)
ONE WAY VALVE INSP (500)
ONE WAY VALVE:INSP (5X20)
ONE WAY VALVE INSP (200)
ONE WAY VALVE:EXP (5X20)
Peak Air PF9940 Peak Flow Meter
AIRZONE EVALUPEAK ATS CURAPLEX
AIRZONE WHITE (AIRIAL)
AIRZONE BLUE ATS (US) SINGLE
AIRZONE (MEDLINE) 12X36 BOX
AIRZONE BLUE ATS (EUROPE) CE
MWPFM STD ATS CLAM (TRI-ANIM)
MWPFM STD ATS CLAM
MWPFM STD ATS ATM SINGLE
MW STD ATS (MEDLINE) 12X20 BOX
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility