FDA Registration
Active
🇬🇧 United Kingdom
PUREBRAND SLUTIONS LTD
Reg #: 3041276591
·
FEI: 3041276591
·
Expires 2026
Products
18
Proprietary Names
17
Establishment Types
1
Classifications
18
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Registration Details
- Registration Name
- PUREBRAND SLUTIONS LTD
- Registration Number
- 3041276591
- FEI Number
- 3041276591
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13 Hawley Crescent, Work Life
- City
- London England
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K220212
Owner / Operator
- Firm Name
- Purebrand Slutions LTD
- Operator Number
- 10094042
- Address
- 13 Hawley Crescent, Work Life
- City
- London
- State
- England
- Postal Code
- NW1 8NP
- Country
- GB
- Correspondent
- Daniel Grinberg
US Agent
- Business Name
- N/A
- Contact Name
- N/A
- Address
- N/A, N/A
- City
- N/A
- State
- NA
- ZIP
- N/A
- Country
- US
- N/A
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2026-04-22 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2026-04-22 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-04-22 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2026-05-04 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-04-22 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2026-05-04 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2026-06-03 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2026-04-22 |
| Dressing, Wound And Burn, Occlusive | MGP | Class U | Unknown | No | 2026-04-22 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2026-05-04 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2026-05-04 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2026-04-27 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2026-04-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-04-22 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2026-04-22 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2026-05-04 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-05-04 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-05-04 |
Proprietary Names
BD TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
MOLNLYCKE TAPE, BANDAGE, ADHESIVE
Welch Allyn LED Otoscope; Welch Allyn LumiView Clear Single-Use Ear Specula;
MOLNLYCKE DRESSING, WOUND, DRUG,COMBINATION PRODUCT
WELCH ALLYN-BP CUFF,DURASHOCK SPHYGMOMANOMETER,ACCESSORIES
WELCH ALLYN- STETHOSCOPE, MANUAL
BD CONTAINER, SPECIMEN TRANSPORT
MOLNLYCKE DRESSING, WOUND AND BURN, OCCLUSIVE
WELCH ALLYN-AUDIOMETER, POCKET FIBER OTOSCOPE, ACCESSORIES
WELCH ALLYN-LS100 HALOGEN EXAMINATION LIGHT
MOLNLYCKE DRESSING, WOUND, DRUG
MOLNLYCKE DRESSING, WOUND, OCCLUSIVE
WELCH ALLYN- FLEXIPORT BP CUFF
MOLNLYCKE GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE
BD SYRINGE, PISTON
MOLNLYCKE DEVICE, TRANSFER, PATIENT, MANUAL
WELCH ALLYN-CONTINUOUS MEASUREMENT THERMOMETER, PROBE, PROBE KIT
Establishment Types
Export Device to the United States But Perform No Other Operation on Device