Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004530184

FEI Number

3004530184

Entity Name

ANDERSEN CALEDONIA LTD

City/State/Country

Bellshill Scotland, GB

Establishment Address

Caledonian House, Phoenix Crescent, Strathclyde Business Park, Bellshill Scotland ML4 3NJ, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Andersen Caledonia Ltd (Owner Number: 10043114)

Owner / Operator Contact Address

Caledonian House, Phoenix Crescent, Strathclyde Business Park, Bellshill, GB-SCT ML4 3NJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 OpClear® System 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-03-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-08-23
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-06-05
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2023-09-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2013-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-12-27
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-09-14
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2025-09-14
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-14
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-08-28
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-09-14
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-01-22
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2025-09-14
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-06-05
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-03-18
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2025-09-14
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2015-01-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2025-09-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-09-14
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-09-14
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2025-09-14
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2025-09-14
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2013-03-18
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2023-08-01
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-08-01
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2025-02-12
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2025-09-14
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-08-14
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-02-07
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2023-02-07
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2025-09-14
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2025-09-14
LRD	Applicator, Ent Drug	Ear, Nose, Throat	Class 1	874.5220	2025-09-14
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2023-01-27
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-01-27
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-09-14
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2025-09-14
SBA	Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate	Clinical Chemistry	Class 2	862.1357	2025-09-14
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-02-05
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2019-08-04
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2019-08-04
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use	Unknown	Class 3	N/A	2023-01-14
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use	Unknown	Class 3	N/A	2023-01-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-05-14
OMD	Cutaneous Tissue Adhesive With Mesh	General, Plastic Surgery	Class 2	878.4011	2023-09-12
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-14
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	Class 2	878.5050	2025-06-11
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2025-09-14
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

Edwin Lindsay Business: RAF SOLUTIONS USA, INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Andersen Caledonia Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004530184. Last updated year: 2026. Please use registration number 3004530184 when referencing this establishment in official correspondence.