Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016595211

FEI Number

3016595211

Entity Name

DYNAMIC EMS LTD

City/State/Country

Dalgety Bay Fife, GB

Establishment Address

Taxi Way, Hillend & Donibristle Industrial Estate,, Dalgety Bay Fife KY11 9ET, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dynamic EMS Ltd (Owner Number: 10093167)

Owner / Operator Contact Address

Taxi Way, Hillend & Donibristle Industrial Estate,, Dalgety Bay, GB-FIF KY11 9ET, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G2 Wearable Device and Dock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-04-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-04-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-04-10
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-04-10
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2025-04-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-10

Official Correspondent

John Dignan

US Agent Details

Edwin Lindsay Business: RAF Solutions Inc. Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Dynamic EMS 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3026264	MICRO CURRENT TECHNOLOGY, INC.	SEATTLE, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016595211. Last updated year: 2026. Please use registration number 3016595211 when referencing this establishment in official correspondence.