Perfect Medical Industry (VN) Co., Ltd
No description from the company. The catalog line you may see elsewhere is generated by us from the category and location, not a statement by the company.
- Type
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Ho Chi Minh City, Vietnam
- Website
- medicaldevices1.com
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment
- Markets
- Vietnam
What is established and what is not
No researcher review has been written for this company yet. 3 official records from 3 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. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-09. Domain registry record
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950, 2024). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
- 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. checked 2026-08-07. US FDA device establishment registration (openFDA)
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-09. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-09. OpenSanctions
- 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 2026-08-09. FDA
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)
Goods family established: Medical & Healthcare Supplies (official record of a specific product). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Safety & Protective Equipment: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.