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.
南非生产的即时诊断套件和医疗耗材。
生产用于临床和现场诊断环境的快速诊断测试套件、医疗耗材和样本采集设备。为公共卫生项目、私人诊所和实验室提供服务。
- 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
- 医疗保健用品
- Markets
- 南非, 肯尼亚, 尼日利亚, 赞比亚, 莫桑比克
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.