FDA Registration
Active
🇹🇼 Taiwan
VALENTINE INTL. LTD.
Reg #: 8022890
·
FEI: 3926
·
Expires 2026
Products
101
Proprietary Names
100
Establishment Types
3
Classifications
101
Registration Details
- Registration Name
- VALENTINE INTL. LTD.
- Registration Number
- 8022890
- FEI Number
- 3926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8TH FL., NO. 149, SEC. 2,, TA TUNG RD.
- City
- HSICHIH CITY, TAIPEI HSIEN
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K032720
Owner / Operator
- Firm Name
- VALENTINE INTL. LTD.
- Operator Number
- 8022890
- Address
- 8TH FL., NO. 149, SEC. 2,, TA TUNG RD.
- City
- TAIPEI
- State
- TW-NOTA
- Postal Code
- 221
- Country
- TW
US Agent
- Business Name
- Dyna Life Products Inc
- Contact Name
- Zoltan Gyorffy
- Address
- 123 Ne 1st Ave
- City
- DELRAY BEACH
- State
- FL
- ZIP
- 33444
- Country
- US
- [email protected]
- Phone
- 561 2798338
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2001-12-17 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2009-02-09 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2017-08-22 |
| Support Gels | JZR | Class 1 | Immunology | No | 2003-08-27 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 1998-01-22 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-10-20 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2008-10-20 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2001-12-17 |
| Hook, External Limb Component, Mechanical | IQX | Class 1 | Physical Medicine | No | 2026-06-15 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2003-08-27 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2005-11-21 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 1994-09-30 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2016-08-03 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 1998-08-07 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2008-10-20 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2001-12-17 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1998-01-22 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 1998-01-22 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 1998-04-07 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2026-06-15 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2012-11-26 |
| Cane | IPS | Class 1 | Physical Medicine | No | 1998-01-22 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 1990-08-02 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2008-10-20 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 1990-08-02 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2003-08-27 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-10-20 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 1998-01-22 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2008-09-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2003-08-27 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 1994-09-30 |
| Urinal | FNP | Class 1 | General Hospital | No | 2001-12-17 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 1990-08-02 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2003-08-27 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1998-04-07 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2003-08-27 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 1998-01-22 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 1998-04-07 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2001-12-17 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 1998-01-22 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2026-06-15 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2003-08-27 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1994-10-14 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2003-08-27 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2012-11-26 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2000-12-08 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 1994-09-15 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-24 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2003-08-27 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-08-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2026-02-03 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2010-06-25 |
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 1992-11-02 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 1998-04-07 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 1997-10-24 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2010-06-23 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2005-11-21 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2003-08-27 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2008-10-20 |
| Cannulae, Bronchial | KCE | Class 1 | General, Plastic Surgery | No | 2003-08-27 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2003-08-27 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2001-12-17 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 1998-01-22 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1998-04-07 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 1992-11-02 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2012-05-31 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2012-11-28 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2002-04-15 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 1998-11-10 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2000-12-08 |
| Percussor | GWZ | Class 1 | Neurology | No | 1998-01-22 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-09-11 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 1997-10-24 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 1990-08-02 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2002-04-15 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1994-08-24 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 1997-10-28 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-06 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2010-09-08 |
| Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | EYT | Class 1 | Gastroenterology, Urology | No | 1997-10-24 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 1997-10-28 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2003-08-27 |
| Footrest, Wheelchair | IMM | Class 1 | Physical Medicine | No | 1998-01-22 |
| Sling, Overhead Suspension, Wheelchair | INE | Class 1 | Physical Medicine | No | 2003-08-27 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-02-26 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 1998-08-14 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2013-01-17 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 1994-08-23 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2019-04-18 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 1998-01-22 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 1998-04-07 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1998-01-22 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 1994-09-30 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 1998-04-07 |
| Scale, Platform, Wheelchair | INF | Class 1 | Physical Medicine | No | 1999-10-19 |
| Board, Bed | FPS | Class 1 | General Hospital | No | 2003-08-27 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 1997-10-28 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2003-08-27 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2012-11-26 |
| Pump, Nebulizer, Electrically Powered | JPW | Class 1 | Ear, Nose, Throat | No | 1990-08-02 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 2000-12-08 |
Proprietary Names
ORTHOSIS, LUMBO-SACRAL
Cast Shoe
Urine Bag
SUPPORT GELS
Patient Lift
Stimulator, nerve, transcutaneous, for pain reliefStimulator, muscle, powered
SLING, ARM
Cervical Collar
Table, mechanical
Flotation Cushion
Massager, therapeutic, electric
Exerciser
Ice Bag
Nebulizer
Bath, sitz, nonpowered
Tongue Depressor
CHAIR AND TABLE, MEDICAL
HALTER, HEAD, TRACTION
Commode, Toilet Support Rail, Grabber, Stool
Sheath
Cane
Chair with Casters
compressor / nebulizer
Crutch
SPLINT, HAND, AND COMPONENTS
Electrode, cutaneous
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
COVER, LIMB
TAPE, MEASURING, RULERS AND CALIPERS
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
URINAL
TIPS AND PADS, CANE, CRUTCH AND WALKER
Liquid dispenser
Measuring Gauge
Dynamometer
COMPONENTS, WHEELCHAIR
Patient Transfer Aid
COVER, MATTRESS
ORTHOSIS, RIB FRACTURE, SOFT
Pill Box Organizer
LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
Overdoor Traction & Pulley Kit
SPLINT, EXTREMITY, INFLATABLE, EXTERNAL
Dressing
Bedpan
ORTHOSIS, ABDOMINAL
Operating Mask
BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
Tape and bandage, adhesive
Underpad
Chair Mechanical
Holder for crutch, cane, wheelchair
Overdoor Traction
Pedal Exerciser
Massager, manual
Wheelchair Cushion
Scale
blood pressure cuff
CANNULAE, BRONCHIAL
UTENSIL, EATING
Orthosis, cervical
Stethoscope
Limb Brace
ATTACHMENT, COMMODE, WHEELCHAIR
Magnifier
Elastic Bandage
Wheelchair Accessory
Transfer Aid
CONTAINER, LIQUID MEDICATION
PERCUSSOR
Surgical Mask
Cast Cover
Walker
Sphygmomanometer
IV Stand
ACCESSORIES, WHEELCHAIR
Surgical Apparel
AC Powered Bed
SHEATH, CORRUGATED RUBBER, FOR NONINDWELLING CATHETER, STERILE
ARMREST, WHEELCHAIR
Protector Skin
Wheelchair Footrest
SLING, OVERHEAD
Nasal Cannula
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB
Insoles
COVER, SHOE, OPERATING-ROOM
Otoscope
Manual Bed
COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
Eye Shield
SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE
Headrest
SCALE, PLATFORM, WHEELCHAIR
Bed Board
BOTTLE, HOT/COLD WATER
BLADE, SCALPEL
Non-Inflatable Split
PUMP, NEBULIZER, ELECTRICALLY POWERED
Stool
Establishment Types
Remanufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device