Medispec
Produttore di guanti chirurgici ed da esame Puchong certificato ISO 13485.
Medispec è un produttore malese di guanti medici con sede a Puchong, Selangor. L'azienda produce guanti chirurgici ed da esame per professionisti del settore medico ed esporta in Europa, Nord America e Australia secondo gli standard di gestione della qualità ISO 13485.
- Type
- brand seeking distribution
- Location
- Puchong, Malaysia
- Founded
- 2001
- Website
- medispec.com.my
- Categories
- Forniture medicali e sanitarie
- Markets
- Stati Uniti, Regno Unito, Australia, Germania
Verified facts
- places-goods-on-market (green), checked 2026-08-19 MDA MMDR (Malaysia Medical Device Register, Medical Device Authority), public search
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
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)