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.
Point-of-care diagnostische kits en medische verbruiksartikelen geproduceerd in Zuid-Afrika.
Produceert snelle diagnostische testkits, medische verbruiksartikelen en apparaten voor monsterafname voor klinische en velddiagnostische omgevingen. Levert volksgezondheidsprogramma's, privéklinieken en laboratoria.
- 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
- Medische en gezondheidszorgbenodigdheden
- Markets
- Zuid-Afrika, Kenia, Nigeria, Zambia, Mozambique
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.