Authorised representative (AR)
Hong Kong and Macau Regulatory Service
香港及澳门法规服务有限公司
Hong Kong MDACS·3 represented devices·1 applicant·Aug 28, 2015 – Sep 24, 2015
3
Total devices
1
Applicants
2015
First representation
2015
Most recent
AR overview
Bilingual authorised representative information and contact details
- Authorised representative (EN)
- Hong Kong and Macau Regulatory Service
- Authorised representative (ZH)
- 香港及澳门法规服务有限公司
- Phone
- 92234360
Timeline
- First representation
- Aug 28, 2015
- Most recent
- Sep 24, 2015
Risk class distribution
II
1
III
2
Applicant partnerships
Top manufacturers represented by this AR
Recent registrations
Latest 15 MDACS listings represented by Hong Kong and Macau Regulatory Service
| Device | Risk class | Applicant | Registered |
|---|---|---|---|
| Prosthesis Implantation Instruments, Orthopedic 假体植入器械,骨科 | II | K2M, Inc. K2M (Va) | Sep 24, 2015 |
| Orthopedic Internal Fixation Systems, Spinal 骨科内固定系统,脊柱 | III | K2M, Inc. K2M (Va) | Aug 28, 2015 |
| Orthopedic Internal Fixation Systems, Spinal 骨科内固定系统,脊柱 | III | K2M, Inc. K2M (Va) | Aug 28, 2015 |
About this profile
Hong Kong and Macau Regulatory Service serves as the authorised representative for 3 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.