FDA Registration
Active
🇹🇼 Taiwan
JIUNDAR INDUSTRIAL CO., LTD.
Reg #: 3003855936
·
FEI: 3003855936
·
Expires 2026
Products
42
Proprietary Names
49
Establishment Types
3
Classifications
42
Registration Details
- Registration Name
- JIUNDAR INDUSTRIAL CO., LTD.
- Registration Number
- 3003855936
- FEI Number
- 3003855936
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.9, ALLEY 2, LANE 252, SAN JIUN STREET
- City
- SHULIN CITY Taipei
- Country
- TW
Owner / Operator
- Firm Name
- JIUNDAR INDUSTRIAL CO., LTD.
- Operator Number
- 9057413
- Address
- NO.9, ALLEY 2, LANE 252, SAN JIUN STREET
- City
- SHULIN CITY
- State
- TW-NOTA
- Postal Code
- 238
- Country
- TW
US Agent
- Business Name
- PE International, Inc.
- Contact Name
- Eva Shu
- Address
- 4372 Lombard Avenue
- City
- Fremont
- State
- CA
- ZIP
- 94536
- Country
- US
- [email protected]
- Phone
- 510 8180828
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2014-12-11 |
| Assembly, Knee/Shank/Ankle/Foot, External | ISW | Class 2 | Physical Medicine | No | 2003-07-31 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-05-27 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2004-06-10 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2003-07-31 |
| Twister, Brace Setting | ITO | Class 1 | Physical Medicine | No | 2004-10-20 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2004-10-19 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2017-03-07 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2003-07-31 |
| Belt, Pelvic, Traction | HSQ | Class 1 | Orthopedic | No | 2004-10-20 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2003-08-27 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2003-07-31 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2006-03-21 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2022-11-25 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2007-05-03 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2003-07-31 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2004-10-20 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 2012-05-24 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2004-10-20 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2014-05-27 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2004-10-19 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2004-10-20 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2005-06-07 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2004-10-20 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2005-01-21 |
| Head Halter, Traction | IRS | Class 1 | Physical Medicine | No | 2004-10-20 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2004-10-20 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2003-08-27 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2015-03-17 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2004-10-19 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2003-07-31 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2020-10-06 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2004-10-20 |
| Binder, Perineal | FQK | Class 1 | General Hospital | No | 2004-10-20 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2004-10-20 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2003-08-07 |
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2004-10-20 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2022-11-25 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2006-03-21 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2004-10-19 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2003-08-27 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2003-07-31 |
Proprietary Names
THREE PANEL KNEE SPLINT
ANKLE SPLINT
Component of Disposal Medical Bedding
HERNIA GASTROENTEROLOGY-UROLOGY
Multiple Component
Multiple
BACK SUPPORT
ANKLE SUPPORT
BACK SUPPORT ELBOW SUPPORT
KNEE SUPPORT
KNEE SLEEVE
KNEE IMMOBILIZER
KNEE SPLINT
ARM PHYSICAL MEDICINE
BRACE
CAST SHOE
WLAKER
OPERATIVE POST SHOE
UNIVERSAL
PREMIUM
CORRECTIVE SHOE#PHYSICAL MEDICINE
CERVICAL#PHYSICAL MEDICINE
Virtual Hip Joint and PJ Joints, Multiple
INP - TIPS AND PADS, CANE, CRUTCH AND WALKER
VELPEAU SLING
DENIM SLING
CRISS-CROSS
UNI-BACK
Component of Hip Joint
STOCKING
AL PURPOSES) GENERAL HOSPITAL
MEDICAL SUPPORT (FOR GENERAL MEDIC
SUSPENSORY
CENTEC
BANDAGE COVERS
CAST
SUPPORTS
UNI-BACK-L-S BRACES
AND COMPONENTS#PHYSICAL MEDICINE
EXTERNAL BRACE PHYSICAL MEDICINE
HEEL PROTECTOR
, UNIVERSAL
ABDOMINAL#PHYSICAL MEDICINE
IPT - ORTHOSIS, THORACIC
PELVIC SUPPORT PHYSICAL MEDICINE
BAND OR BELT
ANKLE EXTERNAL BRACE
STANDARD & PREMIUM
INSOLE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)