EMG Technology Co., Ltd.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
EMG ist seit über 20 Jahren ein professioneller Hersteller im Bereich Medizinprodukte. Zu unseren Qualitätsprodukten gehören Sauerstoffkonzentrator, Saugeinheit und Kompressorvernebler. Sie sind alle nach ISO13485:2016, FDA, CE und GMP zertifiziert.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Taichung City, Taiwan
- Website
- https://emgtech.com.tw
- Categories
- Medizin- & Gesundheitsbedarf
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 6 official records from 5 official sources are on file. 3 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-22. Mail server of the company domain
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-22. FDA
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-22. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-22. OpenSanctions
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. effective since 2026-08-17. US FDA device establishment registration (openFDA)
- Registered with the state to export across borders (record type: export-registered) [official record; status green] A state or statutory export body lists this company as a registered exporter. It shows the registration, not that any shipment took place or that a particular product may be exported. checked 2026-10-16. Taiwan International Trade Administration, import/export firm registry (BOFT)
- Line of business as recorded in the state register: 其他醫療器材及用品製造 (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-16. Taiwan Ministry of Finance, national business tax registration
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-10-16. Taiwan International Trade Administration, import/export firm registry (BOFT)
Relationships
2 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- 3003803075: Site named in the record, registry number 3003803075. US FDA device establishment registration (openFDA)
Candidates, not confirmed
- emgtech.com.tw: Website of this business. Source record
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)