# BIOTEM CO., LTD.

FEI: 3009611645
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Biotem Co., Ltd. (#10057313)

Address: # 422, Sasang-ro, Sasang-gu, Busan, 46925, KR

Mandatory US Agent: BIOTEM USA

## Products

Total registered: 2
Top product codes: DZE, NHA
Regulation §: 872.3640, 872.3630

Proprietary names: Primus Implant System, AR_N Type Implant System

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223009611645%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3009611645