Prima Medi
医疗器械手套及保健用品批发
Prima Medi 是一次性手套的授权经销商。金奈公司还向专业客户批发医疗保健和医疗设备。
- Type
- distributor (our classification of the record, not a statement by the company)
- Role
- Distributor
- Location
- Chennai, India
- Website
- primamedi.in
- Categories
- 医疗保健用品, 安全及防护设备
- Markets
- 印度
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- debarment-clear (green), checked 2026-08-09 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-09 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- domain-registered (green), checked 2026-08-09 Domain registry 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)
- Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)