FDA Registration
Active
🇬🇧 United Kingdom
PROMEDICS ORTHOPAEDIC LTD
Reg #: 3007853907
·
FEI: 3007853907
·
Expires 2026
Products
9
Proprietary Names
25
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- PROMEDICS ORTHOPAEDIC LTD
- Registration Number
- 3007853907
- FEI Number
- 3007853907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Port Glasgow Ind Est, Gareloch Road
- City
- Port Glasgow Scotland
- Country
- GB
Owner / Operator
- Firm Name
- Promedics Orthopaedic Ltd
- Operator Number
- 10034658
- Address
- Port Glasgow Ind Est, Gareloch Road
- City
- Port Glasgow
- State
- Scotland
- Postal Code
- PA14 5XH
- Country
- GB
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-02-13 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2023-02-13 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-08-28 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2023-02-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2010-12-20 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2023-02-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-11-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2022-12-16 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2025-06-11 |
Proprietary Names
Pro Tem Belt
Maternity Support
ProForm Back Support
Hernia Belt
Fixstep
Lacer
UNIVERSAL PLANTAR FASCIITIS ORTHOSIS
Clavicle Splint
Delta & Freedom
Liberty
Abdominal Binder
Ascender Post-Op ROM Knee Brace
Lancaster Shoulder Sling
Jura Wrist Thumb Brace
Jura Thumb Brace
Ascender Elbow Brace
Jura Three Panel Immobilizer
Jura Resting Splint
Paladin XT
JURA ABDUCTION SLING
Philadelphia Style Collar
Foam Collar
Budget Collar
Extraction Collar
Cryo Cold Therapy System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility