Xstrahl L T D

FDA Filings

This page includes the latest FDA filings for Xstrahl L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004561814
• FEI Number: 3004561814
• Name: XSTRAHL LIMITED
• Owner & Operator: XSTRAHL LIMITED
• Contact Address: THE COLISEUM WATCHMOOR PARK, RIVERSIDE WAY; CAMBERLEY GB-SRY Surrey GU15 3YL GB
• US Agent:
  • Adrian Treverton
  • XSTRAHL, INC.
  • 678 4826800
  • 678 4826883
  • adriantreverton@xstrahl.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: UNIT 2 MAYBROOK INDUSTRIAL ESTATE MAYBROOK ROAD, WALSALL WOOD; BROWNHILLS Walsall, WS8 7DG GB
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 9681825
• FEI Number: 1000195405
• Name: XSTRAHL LIMITED
• Owner & Operator: XSTRAHL LIMITED
• Contact Address: THE COLISEUM WATCHMOOR PARK, RIVERSIDE WAY; CAMBERLEY GB-SRY Surrey GU15 3YL GB
• US Agent:
  • Adrian Treverton
  • XSTRAHL, INC.
  • 678 4826800
  • 678 4826883
  • atreverton@xstrahl.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: THE COLISEUM, WATCHMOOR PARK RIVERSIDE WAY; CAMBERLEY Surrey, GU15 3YL GB
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3006740096
• FEI Number: 3006740096
• Name: XSTRAHL, INC.
• Owner & Operator: XSTRAHL LIMITED
• Contact Address: THE COLISEUM WATCHMOOR PARK, RIVERSIDE WAY; CAMBERLEY GB-SRY Surrey GU15 3YL GB
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 480 Brogdon Rd Ste 100 ; Suwanee, GA 30024 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 05060494200084 XSTRAHL LIMITED	X80 / RADiant / PhotoElectric Therapy System	2024-05-16
GUDID 05060494200077 XSTRAHL LIMITED	Xstrahl 300 X-Ray System Ceiling	2018-03-29
GUDID 05060494200060 XSTRAHL LIMITED	Xstrahl 300 X-Ray System - Floor	2018-03-29
GUDID 05060494200053 XSTRAHL LIMITED	Xstrahl 200 X-Ray System - Ceiling	2018-03-29
GUDID 05060494200046 XSTRAHL LIMITED	Xstrahl 200 X-Ray System - Floor	2018-03-29
GUDID 05060494200039 XSTRAHL LIMITED	Xstrahl 150 X-Ray System - Ceiling	2018-03-29
GUDID 05060494200022 XSTRAHL LIMITED	Xstrahl 150 X-Ray System Floor	2018-03-29
GUDID 05060494200015 XSTRAHL LIMITED	Xstrahl 100 X-Ray System	2018-03-29
GUDID 05060494200008 XSTRAHL LIMITED	Xstrahl Photoelectric Therapy System	2018-03-29
PMN K172080 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	Photoelectric Therapy System	2017-11-10
PMN K172080 | JAD XSTRAHL LIMITED	Photoelectric Therapy System	2017-11-10
PMN K172080 | JAD XSTRAHL LIMITED	Photoelectric Therapy System	2017-11-10
PMN K172080 Xstrahl Ltd.	Photoelectric Therapy System	2017-09-29
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	Xstrahl 300	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	Xstrahl 200	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	Xstrahl 150 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	Xstrahl 100 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	MODEL NO'S D3100	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	D3300	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	D3225	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	D3150	2004-05-07
PMN K962613 | JAD XSTRAHL, INC. [XSTRAHL LIMITED]	D3100	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 300	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 300	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 200	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 200	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 150 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 150 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 100 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	Xstrahl 100 electronic brachytherapy	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	MODEL NO'S D3100	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	MODEL NO'S D3100	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3300	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3300	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3225	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3225	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3150	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3150	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3100	2004-05-07
PMN K962613 | JAD XSTRAHL LIMITED	D3100	2004-05-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090553891	London,United Kingdom -> Charleston, South Carolina	MEDICAL EQUIPMENT	1 CRT
2019102860700	London,United Kingdom -> Charleston, South Carolina	MEDICAL EQUIPMENT	3 CRT
2019021854530	London,United Kingdom -> Charleston, South Carolina	MEDICAL MACHINERY	4 PKG