RPM Core devices are manufactured by Shenzhen AOJ Medical Technology Co., Ltd. Our products meet global regulatory requirements and hold the following certifications:
- ISO 13485
- MDSAP
- ISO 14001
- FDA
- CE MDR / MDD
- NMPA
- BSCI
- SMETA
- RoHS
- REACH
- FSC
- RED
- FCC
- BQB
Certification status is model-specific. Tell us the model and the destination market and we will confirm the certification that applies to that combination, together with the supporting documentation.
Regulatory documentation support
We provide regulatory consulting from early research through clinical trials, testing and global certification, so your brand can enter a market with the documentation it needs already in place.