TESTING · CONSULTING · CERTIFICATION — GLOBAL DEVICE REGISTRATION SEARCH

Medical Device TIC Database

Every manufacturer, one lookup — fourteen official registries, verified record by record. Plus medical device regulations and guidance by jurisdiction, and testing standards with their current versions.

Three databases, three ways to search

Registration search

Companies, registration numbers and products across fourteen official registries

Regulation search

Medical device regulations and guidance, FDA product codes (classification, class, 21 CFR, marketing pathway) and recent 510(k) clearances with archived summaries. Searching by number works best — e.g. MDR 2017/745, 21 CFR 820, QIH, K243456.

Testing search

Standards records, version status, regulatory recognition (FDA, EU harmonised, UK designated, China) and laboratories that can test them. Standard texts are copyrighted — records and official links only.

Jump to a registryChina NMPA European Union EUDAMED United States FDA openFDA United Kingdom MHRA PARD Brazil ANVISA Saudi Arabia SFDA Canada MDALL Taiwan TFDA Singapore HSA SMDR South Korea MFDS GMP Australia TGA ARTG Hong Kong MDACS Israel AMAR Russia Roszdravnadzor

Registrationsfourteen official registries, verified record by record

102,040companies

≥1,154,182registration records in total

101countries and regions

14registries connected

RegulationsRegulations, guidance and updates by jurisdiction

282Regulations and guidance

589Regulatory updates

7,091FDA product codes

9,670510(k) clearances, 3 yrs

Testing standardsStandard records and testing bodies

4,792Testing standards

5,790Standard versions

11Testing bodies

The three databases count different things — do not add the numbers across. Registrations: "companies" counts firms (102,040 listed, 97,609 with at least one registration found); "records" counts certificates, device listings and similar entries, so one company often maps to dozens or hundreds. Each market defines a record differently (the EU counts UDI-DIs, the US listed device types, China certificates), so the total is a rough indication of scale only; "≥" means some companies returned more hits than we verify (first 300), so the real figure is higher. Regulations and testing standards are counted as entries. Full texts are copyrighted — this site provides bibliographic records, version status and official links only, never full-text downloads.

Testing, consulting and certification

CONSULTING · CERTIFICATION

SUNGO regulatory affairs and consulting

The SUNGO brand was founded in 2006.

Our mission is to help health products move across borders; we aim to be the compliance partner our clients trust most.

Group headquarters are in Lujiazui, Shanghai, with six overseas offices — Rotterdam, Düsseldorf, Zug, London, Sydney and Kentucky — providing local representation and device registration, plus three subsidiaries in Wuhan, Guangzhou and Hefei. The group operates two medical device laboratories holding China’s national CMA qualification together with CNAS and IAS accreditation, and an ANAB-accredited medical device quality management system certification body.

www.sungoglobal.com →

TESTING

SUNGO Lab

SUNGO LAB is the group’s medical device testing laboratory and technical platform, accredited to ISO/IEC 17025:2017.

We run two independent laboratories, in Shanghai and Hefei, each holding IAS, CNAS and CMA — so a single test run can produce both the Chinese report needed for domestic registration and the English report accepted overseas.

SUNGO serves clients across six continents and more than 30 countries, over 5,000 companies to date; more than 30% of China’s top-100 medical device makers work with SUNGO.

Electrical safetyEMCISO 7176 wheelchair seriesSterile packaging and transport simulationCleaning / disinfection / sterilisationShelf-life validationDevice performance testing

www.sungolytest.com →

Registry coverage

"Live" means we fetch and verify records automatically. Markets marked "to import" or "coming" have no data and are shown as "pending" — never filled with estimates.

CNChinaNMPApartial

38,717companies matched

nmpa.gov.cn device registration search · 41,098 of 102,040 companies queried · ≥315,469 China registrations (total)

EUEuropean UnionEUDAMEDlive

1,838companies matched

ec.europa.eu/tools/eudamed · ≥150,958 UDI-DI device records (total)

USUnited StatesFDA openFDAlive

26,108companies matched

api.fda.gov / download.open.fda.gov · 282,111 listed device types (total)

UKUnited KingdomMHRA PARDlive

1,214companies matched

pard.mhra.gov.uk · 19,367 registered device records (total)

BRBrazilANVISAlive

11,446companies matched

dados.anvisa.gov.br · 137,976 registered devices (total)

SASaudi ArabiaSFDAlive

4,170companies matched

sfda.gov.sa open data · 52,862 registered imported devices (total)

CACanadaMDALLlive

4,711companies matched

health-products.canada.ca · 57,726 active device licences (total)

TWTaiwanTFDAlive

4,475companies matched

data.fda.gov.tw open data platform · 22,350 valid device licences (total)

SGSingaporeHSA SMDRlive

2,754companies matched

data.gov.sg — Singapore Medical Device Register · 17,270 device registrations (total)

KRSouth KoreaMFDS GMPlive

2,248companies matched

emedi.mfds.go.kr — MFDS medical device GMP audit status · 3,921 GMP quality-system certificates (total)

AUAustraliaTGA ARTGlive

6,591companies matched

compliance.health.gov.au/artg — official ARTG search tool · 48,531 active ARTG entries (total)

HKHong KongMDACSlive

1,550companies matched

mdis.mdd.gov.hk — Medical Device Division, Department of Health · 8,597 valid listings (total)

ILIsraelAMARlive

6,315companies matched

registries.health.gov.il — Ministry of Health medical device registry · 21,073 registrations (total)

RURussiaRoszdravnadzorlive

3,390companies matched

elk.roszdravnadzor.gov.ru — Roszdravnadzor State Register of Medical Devices · 15,971 active registrations (total)

The official source, query path and search field behind every figure is listed under Methodology →

Medical Device TIC Database

Check your overseas registrations

Check a Chinese manufacturer

Install the app

Query dimensions

By market →

By category →

By country →

Testing, consulting and certification

SUNGO regulatory affairs and consulting

SUNGO Lab

Registry coverage