Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007607999

FEI Number

3007607999

Entity Name

TIOGA LIMITED

City/State/Country

DERBY Derbyshire, GB

Establishment Address

ST THOMAS HOUSE, MANSFIELD ROAD, DERBY Derbyshire DE13TN, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TIOGA LIMITED (Owner Number: 10054550)

Owner / Operator Contact Address

ST THOMAS HOUSE, MANSFIELD ROAD, DERBY, GB-DBY DE13TN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Novii+ Monica Novii POD VS Newborn Heart Rate Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-01-25
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	Class 2	884.2720	2017-04-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-02-07

Official Correspondent

ROBIN WALFORD

US Agent Details

Alan Scwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

TIOGA 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
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

Similar Registrations

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3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
1424263	Isomedix Operations, Inc.	Libertyville, IL, US
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007607999. Last updated year: 2026. Please use registration number 3007607999 when referencing this establishment in official correspondence.