FDA Registration
Active
🇲🇾 Malaysia
Intersurgical Medical Sdn. Bhd.
Reg #: 3011503227
·
FEI: 3011503227
·
Expires 2026
Products
6
Proprietary Names
12
Establishment Types
1
Classifications
6
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- Intersurgical Medical Sdn. Bhd.
- Registration Number
- 3011503227
- FEI Number
- 3011503227
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 993,Lorong Perindustrian Bukit Minyak 11, Taman Perindustrian Bukit Minyak
- City
- Simpang Ampat Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- ENGINEERED MEDICAL SYSTEMS
- Operator Number
- 9022693
- Address
- 2055 EXECUTIVE DR., --
- City
- INDIANAPOLIS
- State
- IN
- Postal Code
- 46241
- Country
- US
- Correspondent
- TAMARA - LEFEVERS
US Agent
- Business Name
- ENGINEERED MEDICAL SYSTEMS
- Contact Name
- TAMARA Lefevers
- Address
- 2055 Executive Dr
- City
- Indianapolis
- State
- IN
- ZIP
- 46241
- Country
- US
- [email protected]
- Phone
- 317 2465500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-12-04 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2008-12-09 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2007-12-04 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2018-06-19 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-01-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2021-06-02 |
Proprietary Names
Aero-Pro
Aero-Sat
O2-MAX
O2 Resq
AccuPAP
Go-PAP
VentiSure2
FENEM
VT Select
Aero-T+
Aero-T
1161000
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)