SA Biomedical Group
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.
南アフリカで製造されたポイントオブケア診断キットと医療消耗品。
臨床および現場の診断現場向けの迅速診断検査キット、医療消耗品、検体収集装置を製造しています。公衆衛生プログラム、民間のクリニックや研究所に提供しています。
- 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
- Cape Town, South Africa
- Founded
- 2003 (from our catalogue record; not confirmed by the company or by a state register)
- Website
- https://www.sabio.co.za
- Categories
- 医療およびヘルスケア用品
- Markets
- 南アフリカ, ケニア, ナイジェリア, ザンビア, モザンビーク
What is established and what is not
No researcher review has been written for this company yet. No fact of any kind is on file either. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
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)
Check independently
Before a first order, ask for the legal entity's registration number and country, then check it in the official register.