FDA Registration
Active
🇬🇧 United Kingdom
ANDERSEN CALEDONIA LTD
Reg #: 3004530184
·
FEI: 3004530184
·
Expires 2026
Products
72
Proprietary Names
71
Establishment Types
1
Classifications
72
Registration Details
- Registration Name
- ANDERSEN CALEDONIA LTD
- Registration Number
- 3004530184
- FEI Number
- 3004530184
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Caledonian House, Phoenix Crescent, Strathclyde Business Park
- City
- Bellshill Scotland
- Country
- GB
Owner / Operator
- Firm Name
- Andersen Caledonia Ltd
- Operator Number
- 10043114
- Address
- Caledonian House, Phoenix Crescent, Strathclyde Business Park
- City
- Bellshill
- State
- Scotland
- Postal Code
- ML4 3NJ
- Country
- GB
US Agent
- Business Name
- RAF SOLUTIONS USA, INC
- Contact Name
- Edwin Lindsay
- Address
- 10124 N.W. 53rd Street, Sunrise
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33351
- Country
- US
- [email protected]
- Phone
- 305 9607262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-03-18 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-08-23 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2013-06-05 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2023-09-12 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2013-03-14 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-12-27 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2025-09-14 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2019-08-28 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2025-09-14 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2016-01-22 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2013-06-05 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-03-18 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2025-09-14 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2025-09-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2013-03-18 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2023-08-01 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2023-08-01 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Intraoperative Orthopedic Joint Assessment Aid | ONN | Class 2 | Neurology | No | 2025-02-12 |
| Regulator, Vacuum | KDP | Class 2 | General Hospital | No | 2025-09-14 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2022-08-14 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2023-02-07 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2023-02-07 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2025-09-14 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2025-09-14 |
| Applicator, Ent Drug | LRD | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2025-09-14 |
| Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | SBA | Class 2 | Clinical Chemistry | No | 2025-09-14 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2023-02-05 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Continuous Glucose Monitor, Implanted, Adjunctive Use | QCD | Class 3 | Unknown | No | 2023-01-14 |
| Sensor, Glucose, Implanted, Non-Adjunctive Use | QHJ | Class 3 | Unknown | No | 2023-01-14 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2020-05-14 |
| Cutaneous Tissue Adhesive With Mesh | OMD | Class 2 | General, Plastic Surgery | No | 2023-09-12 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2020-05-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-01-14 |
| Surgical Smoke Precipitator | PQM | Class 2 | General, Plastic Surgery | No | 2025-06-11 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 2025-09-14 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2025-09-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Tissue Adhesive Internal Use | PLJ | Class 3 | General, Plastic Surgery | No | 2023-09-12 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2025-09-14 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2025-09-14 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2025-09-14 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2017-01-27 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2025-09-14 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2025-09-14 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2013-04-08 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 2025-09-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2020-05-14 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-02-24 |
Proprietary Names
FORCEPS, ENT
Disposable Intraoperative Probe (DIOP8)
CURETTE, EAR
LiquiBand,Flow Control, Swiftset, LiquiBand Butyl
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
CUTTER, WIRE
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
SCISSORS, GENERAL, SURGICAL
CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
DSP002 - Medium Disposable Speculum
TRP001 - Dispoable Treatment Pipe
DSP003 - Large Disposable Speculum
DSP001 - Small Disposable Speculum
SCISSORS, OPHTHALMIC
HEMOSTAT
TUBING, NONINVASIVE
CATHETER AND TIP, SUCTION
FORCEPS
ACCESSORIES, CATHETER
INSTRUMENT, LIGATURE PASSING AND KNOT TYING
HOLDER, EAR SPECULUM
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
PROBE, ENT
Quadsense
REGULATOR, VACUUM
SAFIRA
OpClear® Control Unit
OpClear® CS-CU15-03
OpClear® System
OpClear® Platform
OpClear® Disposable Procedure Kit
OpClear® Disposable
SOUND, UTERINE
DILATOR, TRACHEAL
FORCEPS, BIOPSY, GYNECOLOGICAL
APPLICATOR, ENT DRUG
SC+ Blood Tube Set
INSTRUMENT, SURGICAL, DISPOSABLE
SPECULUM, VAGINAL, METAL
CURETTE, ADENOID
TUBE, EAR SUCTION
PICK, MICROSURGICAL EAR
Eversense Continuous Glucose Monitoring System (Sensor)
Eversense E3 Continuous Glucose Monitoring System (Sensor)
Sterile Kleen Blade Management System
LiquiBand XL, LiquiBand Secure
Sterile Retractable Disposable Stitch Cutter Scalpe
Neuromark System
Ionwand Sterile Pack
EXCAVATOR, EAR
CURETTE, NASAL
PUNCH, BIOPSY, SURGICAL
Syringe, cartridge
RETRACTOR
LIQUIFIX FIX8, LIQUIFIX Precision Open
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
RONGEUR
FORCEPS, DRESSING, DENTAL
SCISSORS, EAR
INSTRUMENT, ENT MANUAL SURGICAL
FORCEPS, GENERAL & PLASTIC SURGERY
Lotus Series 4 Ultrasonic Surgical System & Accessories
TUBE, TONSIL SUCTION
DEPRESSOR, TONGUE, NON-SURGICAL
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
LiquiBand Rapid
HOLDER, SPECULUM, ENT
Sterile Retractable Disposable Scalpels
ACTIVHEAL® PHMB FOAM SILICONE ADHESIVE BORDER
GEMCORE 360 PHMB Silicone Border Foam Dressing
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)