FDA Registration
Active
🇮🇩 Indonesia
PT. TRANSMEDIC INDONESIA
Reg #: 3009251316
·
FEI: 3009251316
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- PT. TRANSMEDIC INDONESIA
- Registration Number
- 3009251316
- FEI Number
- 3009251316
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Perkantoran Menara ERA, Unit G-01, Jl. Senen No. 135-137
- City
- Jakarta
- Country
- ID
Owner / Operator
- Firm Name
- PT. Transmedic Indonesia
- Operator Number
- 10095308
- Address
- Perkantoran Menara ERA, Unit G-01, Jl. Senen No. 135-137
- City
- Jakarta
- State
- ID-JK
- Postal Code
- 10410
- Country
- ID
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2026-02-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2026-02-23 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2026-02-23 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2026-02-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-02-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-02-23 |
Proprietary Names
Apparatus, traction, non-powered
orthopedic manual surgical instrument
Accessories, arthroscopic
table and attachments, operating-room
instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device