Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010439239

FEI Number

3010439239

Entity Name

MEDITECH SYSTEMS LIMITED

City/State/Country

Shaftesbury Dorset, GB

Establishment Address

shrublands Estate, Shearstock, Shaftesbury Dorset SP79PT, GB

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Meditech Systems Limited (Owner Number: 10048739)

Owner / Operator Contact Address

shrublands Estate, shearstock, shaftesbury, GB-DOR SP79PT, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDIZIP Meditech Meditech Meditech Meditech Meditech Meditech Meditech Meditech Meditech Breathing Bag 2 Litre Meditech Breathing Bag 3 Litre Meditech Breathing Bag 1 Litre Meditech Breathing Bag 0.5 Litre Meditech Anesthesia Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-06-07
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-02-20
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2020-12-17
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2015-02-20
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2015-02-20
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2015-02-20
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2015-02-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2021-06-29
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2015-11-26
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2025-05-17
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2024-05-28

Official Correspondent

Gordon clowrey

US Agent Details

Alfred Kelly Email: kelgorinc@gmail.com Phone: (920) 9606662

Related Public Records

Same Entity

Meditech Systems Limited

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010439239. Last updated year: 2026. Please use registration number 3010439239 when referencing this establishment in official correspondence.