DIGITIMER LTD.

FDA Device Registration & Listing · Welwyn Garden City Hertfordshire, GB · Registration 3003631667

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003631667
FEI Number
3003631667
Entity Name
DIGITIMER LTD.
City/State/Country
Welwyn Garden City Hertfordshire, GB
Establishment Address
37 HYDEWAY, Welwyn Garden City Hertfordshire AL7 3BE, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
DIGITIMER LTD. (Owner Number: 9043315)
Owner / Operator Contact Address
37 HYDEWAY, WELWYN GARDEN CITY, HERTFORDSHIRE, GB-NOTA AL7 3BE, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Digitimer DS7AP Constant Current Stimulator Digitimer Urodynamics Catheters & Accessories D185 MultiPulse Cortical Stimulator DS7AH Constant Current Stimulator Cuillin Nanolgger

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2018-09-12
EYK Connector, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2019-07-19
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2007-12-03
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2007-12-03
EXQ Cystometer, Electrical Recording Gastroenterology, Urology Class 2 876.1620 2019-05-15

Official Correspondent

No official correspondent registered.

US Agent Details

Steven Valenti Business: Digitimer North America, LLC Email: svalenti@digitimer.com Phone: (954) 3341070

Related Public Records

Same Entity

DIGITIMER 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
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003631667. Last updated year: 2026. Please use registration number 3003631667 when referencing this establishment in official correspondence.
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