Neurotech Philippines, Inc.
EMS specializing in medical and industrial sensor modules, with in-house SMT and cleanroom assembly.
Neurotech manufactures PCB assemblies and complete devices for medical diagnostic, environmental monitoring, and factory automation OEMs. The company is ISO 13485 certified and handles low to medium volume production.
- Type
- Manufacturer
- Location
- Laguna, Philippines
- Website
- neurotech.com.ph
- Categories
- Consumer Electronics, Medical & Healthcare Supplies
- Markets
- Japan, United States, Germany, South Korea, China
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)