Data / Medical devices / Indonesia / Sugih Instrumendo Abadi, PT
Sugih Instrumendo Abadi, PT: FDA-registered device maker in Bandung Barat Jawa Barat, Indonesia, 1 510(k) clearance
Sugih Instrumendo Abadi, PT is registered with the FDA (registration 9710103) in Bandung Barat Jawa Barat, Indonesia. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710103
- FEI number
- 3002118752
- Address
- JL. TEMBOKAN RT.1/01, DS. CIPEUNDEUY, Padalarang, Bandung Barat Jawa Barat, Indonesia, 40553
- Owner or operator
- SUGIH INSTRUMENDO ABADI, PT (9045100)
- Roles
- Manufacturer
- First device listed
- February 3, 2004
- Registered through
- 2026
- Brand names listed
- Aluminum Stethoscope, Lightweight Stethoscope, Sprague Rappaport, Stainless Steel Stethoscope, Stethoscope Parts
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 16, 2001 | K012444 | ABN ANEROID SPHYGMOMANOMETER | DXQ | Substantially Equivalent | Pt. Sugih Instrumendo Abadi | accessdata.fda.gov |
Compare with other makers
- All makers of Stethoscope, Manual
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Blood Pressure Cuff
- All makers of Infusor, Pressure, For I.V. Bags
- All makers of Splint, Hand, And Components
Updated August 16, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.