FDA Registration
Active
🇮🇩 Indonesia
PT. Jayamas Medica Industri Tbk
Reg #: 3017635043
·
FEI: 3017635043
·
Expires 2026
Products
14
Proprietary Names
13
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- PT. Jayamas Medica Industri Tbk
- Registration Number
- 3017635043
- FEI Number
- 3017635043
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sebelah Selatan Jalan By Pass, Ds., Sidomojo, Krian
- City
- Sidoarjo Jawa Timur
- Country
- ID
Owner / Operator
- Firm Name
- One Medical Health Care
- Operator Number
- 10078103
- Address
- Sebelah Selatan Jalan By Pass, Ds., Sidomojo, Krian
- City
- Sidoarjo
- State
- Jawa Timur
- Postal Code
- 61262
- Country
- ID
US Agent
- Business Name
- medapproval llc
- Contact Name
- william slevin
- Address
- 730 E Suber Rd
- City
- Greer
- State
- SC
- ZIP
- 29650
- Country
- US
- [email protected]
- Phone
- 404 5935005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2020-10-10 |
| Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | MPQ | Class 1 | Pathology | No | 2020-10-10 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-05-19 |
| Stethoscope Head | BZS | Class 1 | Anesthesiology | No | 2020-10-10 |
| Feeding Tube Kit | PRR | Class 2 | Gastroenterology, Urology | No | 2025-06-01 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2021-05-18 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2020-10-10 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2021-05-18 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2021-05-18 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2021-05-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-06-01 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-05-19 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-10-10 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2025-12-03 |
Proprietary Names
One Medical Alcohol Pad
One Medical Urine Specimen Container
One Medical Syringe
One Medical Head
Feeding Tube Kit
One Medical Lubricant
One Medical Suction
One Medical Clamp
One Medical Specimen Container
Sterile Specimen Container
One Medical Suction Catheter
Bandage
Medline Umbilical Cord Clamp
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)