Vietnam MOH registration 240000029/PCBA-HCM
IVD is the module for drug testing, heating, shaking, and cooling
VN: IVD là mô-đun thêm thuốc thử, gia nhiệt, lắc và làm nguội
Vietnam·Risk Class TTBYT Loại A·cobas® prime Process Plus Module·Hamilton Bonaduz AG·Registered Jan 04, 2024Registration details
- Analysis ID
- 240000029/PCBA-HCM
- Submission ID
- 000.00.19.H29-231229-0004
- Product Type
- cobas® prime Process Plus Module
- Product Code
- 08987963001
Company information
- Manufacturer
- Hamilton Bonaduz AG
- Manufacturer Country
- SWITZERLAND
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
Technical details
- Intended Use
- The supplementary processing module is used to add reagents, heat, shake, and cool. It is an optional module, required only for certain work processes and for the closed-loop operation mode. The supplementary processing module is commonly used in conjunction with the cobas® prime pre-analytical system.
Dates and status
- Registration Date
- Jan 04, 2024
About this record
Access comprehensive regulatory information for IVD is the module for drug testing, heating, shaking, and cooling in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000029/PCBA-HCM and manufactured by Hamilton Bonaduz AG. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI300,000+ Devices