Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021788

FEI Number

5682

Entity Name

Timesco Healthcare Ltd

City/State/Country

Basildon Essex, GB

Establishment Address

3 Carnival Close, Basildon Essex SS14 3WN, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Timesco Healthcare Ltd (Owner Number: 8021788)

Owner / Operator Contact Address

3 Carnival Park, Carnival Close, Basildon, GB-ESS SS14 3WN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orion Diagnostic Cutter, Surgical Stethoscope Magill Intubation Forceps ION, Timesco ION R, ION R, Timesco Timesco Xenon Sirius Eclipse, Optima Eclipse, Timesco ION Optima XL Fibre Optic Shakerscope, Shakerscope, Timesco Single Use Skin Timesco XLED Optima Clx FIbre Optic Optima Fibre Optic Timesco R, ION R Charger, Timesco EES Energy Efficient Systems Callisto Fibre Optic Disposable Lunar Conventional Easy Bright Laryngoscope Sirius Fibre Optic Freeway Plastic Disposable Europa Disposable Optima View RU Blade Video Laryngoscope Optima View SU Blade Video Laryngoscope Forceps Curette Orion Dermatoscope Eisenhammer Rectal Speculum Single-Use TourniButton Tourniquet Single-Use Tourniquet Band Type

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2000-03-01
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1993-03-08
HTX	Rongeur	Orthopedic	Class 1	888.4540	1983-10-24
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2004-06-03
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	1993-03-31
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1993-03-08
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2021-06-08
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2006-05-11
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1983-10-24
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1983-10-24
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2011-07-20
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2010-03-19
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2018-07-09

Official Correspondent

No official correspondent registered.

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

Timesco Healthcare 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

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

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3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL
9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021788. Last updated year: 2026. Please use registration number 8021788 when referencing this establishment in official correspondence.