FDA Registration
Active
🇲🇾 Malaysia
TECAN CDMO SOLUTIONS PN SDN. BHD.
Reg #: 3015134086
·
FEI: 3015134086
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TECAN CDMO SOLUTIONS PN SDN. BHD.
- Registration Number
- 3015134086
- FEI Number
- 3015134086
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PMT1199 (Plot 372), Penang Science Park, Lorong Perindustrian Bukit Minyak 21, Taman Perindustrian, Bukit Minyak, 14100 Simpang Ampat, Seberang Perai Tengah,
- City
- Penang Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- Tecan Group AG
- Operator Number
- 9050992
- Address
- 103 Seestrasse, --
- City
- Maennedorf
- State
- Zurich
- Postal Code
- 8708
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2024-06-01 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-10-14 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2021-10-14 |
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2021-10-14 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-06-08 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-10-08 |
Proprietary Names
CORE DIGITAL ATTACHMENT PRIMARY BOX FG SKU
KARDIAMOBILE 6L_AliveCor, Inc.
KardiaMobile System
Kardia 12L
Medical Device Data System_Avail Medsystem Inc.
Avive Connect
CORE 500 DIGITAL STETHOSCOPE - STANDARD CHESTPIECE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)