FDA Registration
Active
🇬🇧 United Kingdom
Systagenix Wound Management Manufacturing Limited
Reg #: 3007663067
·
FEI: 3007663067
·
Expires 2026
Products
37
Proprietary Names
55
Establishment Types
2
Classifications
37
Registration Details
- Registration Name
- Systagenix Wound Management Manufacturing Limited
- Registration Number
- 3007663067
- FEI Number
- 3007663067
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Airebank Mill, Gargrave
- City
- North Yorkshire
- Country
- GB
Owner / Operator
- Firm Name
- Systagenix Wound Management Manufacturing Limited
- Operator Number
- 10028771
- Address
- Airebank Mill, Gargrave
- City
- North Yorkshire
- State
- GB-NYK
- Postal Code
- BD23 3RX
- Country
- GB
- Correspondent
- Libby Morrison
US Agent
- Business Name
- Biomed Laboratories Inc
- Contact Name
- Jason Troutman
- Address
- 8181 Eastpoint Dr
- City
- Dallas
- State
- TX
- ZIP
- 75227
- Country
- US
- [email protected]
- Phone
- 949 4197005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2021-09-27 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2020-09-25 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-04-28 |
| Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | QUW | Class 2 | General, Plastic Surgery | No | 2025-08-14 |
| Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | OWX | Class 2 | General, Plastic Surgery | No | 2025-08-14 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2019-11-25 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2026-02-09 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2025-09-17 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2026-02-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2026-02-09 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-11-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2009-09-17 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2023-11-30 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2013-02-15 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2009-05-01 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-11-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2025-09-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-09-25 |
| Probe | HXB | Class 1 | Orthopedic | No | 2022-11-14 |
| Negative Pressure Wound Therapy Non-Powered Suction Apparatus | OKO | Class 2 | General, Plastic Surgery | No | 2018-12-21 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2013-02-20 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2010-11-05 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2018-12-21 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2025-09-17 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2020-06-02 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2019-12-04 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2019-07-16 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2009-03-05 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2009-09-17 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2025-09-17 |
Proprietary Names
Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090, Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1091
Tender Care Hydrogel Pad
MediHoney HCS / HCS Burn Dressing
TekBrace Solo
Poly-Tape, Infinity Lock, AchilloCordPLUS, SIC Graft, FORCEWEB
CC-Hook
Susol® Scissors Iris Fine Point Straight 11.5cm, Susol® Scissors Lister Bandage 18.5cm, Susol® Nipper Thwaites Nail 14cm
Susol® Forceps Artery Halstead Mosquito Curved 12.5cm
Susol® Forceps Dissecting Iris Straight 1:2 Teeth 11.5cm
Susol® Forceps Dissecting Adson Serrated 13cm
Susol® Forceps Dissecting Iris Straight Serrated 11.5cm
Susol® Forceps Rampleys Sponge Holding 18cm
Susol® Forceps Dissecting Adson 1:2 Teeth 13cm
MediHoney Hydrogel
Susol® Nipper General Curved 13cm, Susol® Nipper Ingrown Nail 14cm
Infinity-Lock Button System
Xtrasorb Gentle
Cutimed Sorbion Border
Gentell Hydrogel Acute Surgical Incision Dressings
ActiV.A.C.Canister with Gel
ActiV.A.C.300ml Canister with Gel
Fastlok
Susol® Probe Flat Head Swan Neck 12.5cm, Susol® Blacks File Double Ended Micro with Round Probe 14cm
Susol® Standard Suture Pack
Dr Scholls Blister Cushions
Malleable Probe, Rigid Probe
Susol® Diamond Bur Bud 3, Susol® Diamond Bur Bud 2
Susol® Basic Care Pack
Susol® Partial Nail Avulsion Procedure Pack
Silvercel Non-Adherent Antimicrobial Alginate Dressing
Susol® Micro Curette Double Ended with hole, Susol® House Curette Malleable Double Ended 2mm/3mm Scoops 180mm
Poly-Tape 30mm x 800mm
Susol® Laryngeal Handle & Mirror Size 25mm
Silvercel Antimicrobial Alginate Dressing
Infinity-Lock 5
Infinity-Lock 3
FlexPasser Tendon Retrieval Kit
Pitch Patch Tissue Reinforcement 30mm x 20mm, Pitch Patch Tissue Reinforcement 35mm x 25mm
Poly-Tape 20mm x 800mm, Infinity Lock 5mm x 400mm, Poly-Tape 5mm x 800mm, Infinity Lock 7mm x 400mm, Poly-Tape 15mm x 80
Russell Chest Seal
Xtrasorb HCS
InfoV.A.C.500ml Canister without Gel
InfoV.A.C.500ml Canister with Gel
Susol® Scalpel Handle Badger Fine
L-Mesitran Active
L-Mesitran Hydro
L-Mesitran Border
L-Mesitran Gentell Hydro 12cmx8.5cm
L-Mesitran Gentell Hydro 18cmx12.5cm
L-Mesitran Gentell Hydro 6cmx6cm
Gentell Hydrogel Sheet Dressing
Glacier Gel
Curad Bandage Soothe & Cool
Soothies C-section Recovery Pads
Susol® Blacks File Single Ended Coarse 14cm
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)