FDA Registration
Active
🇲🇾 Malaysia
YCH DISTRIPARK SDN BHD
Reg #: 3010055973
·
FEI: 3010055973
·
Expires 2026
Products
81
Proprietary Names
59
Establishment Types
1
Classifications
81
Registration Details
- Registration Name
- YCH DISTRIPARK SDN BHD
- Registration Number
- 3010055973
- FEI Number
- 3010055973
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 201, Lorong Perusahaan Maju 9,, Taman Perindustrian Bukit Tengah
- City
- Prai Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K220626
Owner / Operator
- Firm Name
- YCH Distripark Sdn Bhd
- Operator Number
- 10041986
- Address
- Plot 201, Lorong Perusahaan Maju 9,, Taman Perindustrian Bukit Tengah
- City
- Prai
- State
- Pulau Pinang
- Postal Code
- 14000
- Country
- MY
- Correspondent
- Nurashikin Ahmad
US Agent
- Business Name
- Qserve Group US Inc
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-12-27 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-12-27 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2022-12-29 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 2022-12-29 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-11-28 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2022-12-29 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2019-07-17 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2019-07-17 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2022-12-29 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-12-27 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-12-27 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2022-12-29 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2022-12-29 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2022-12-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2022-12-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-29 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-12-29 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2022-12-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2022-12-29 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2022-12-29 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2022-12-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-12-29 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2015-12-08 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2022-12-29 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2022-12-27 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2022-12-29 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2022-12-29 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2022-12-29 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2022-12-29 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2022-12-29 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2022-12-29 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2022-12-29 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2022-12-29 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2019-07-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2022-12-29 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2021-12-30 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-12-27 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2022-12-29 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2022-12-29 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2022-12-29 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2013-11-28 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2022-12-29 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2022-12-29 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
Proprietary Names
ORTHOPEDIC CURETTE
Introcan Safety
Aesculap
Forceps
Sterican
PERIODONTIC PROBE
Introcan Safety 2 (multi)
Clamp
INSTRUMENT SURGICAL GUIDE
Handle
Pencan
Retractor
BIOPSY FORCEPS
Blade
Hook
Curette
Introcan Safety 2
Scaler
Spinocan
Dissector
SURGICAL DENTAL ELEVATOR
Orthopedic Instrument
Rasp
OPERATIVE EXCAVATOR
Surgical Instrument
RONGEUR FORCEPS
Holder
Speculum
Scisssors
Applier
Infusion Set, Winged Infusion set
Scissors
Elevator
Depressor
UTERINE CLAMP
SURGICAL CLIP APPLIER
Perifix, Perifix Pediatric
ORTHOPEDIC WIRE TWISTER
AESCULAP
PERIODONTIC KNIFE
Serofine® Needles
Perifix Perifix Tuohy Non-Winged Tuohy Perican Tuohy
SurecanSafety II
Guide
OmnicanFine
Knife
Pencylcap
Spatula
METAL TONGUE DEPRESSOR ENT
Espocan, Espocan Tuohy
Extractor
Introcan Safety 3
Pencan and Spinocan Spinal Introducer Needles
SURGICAL RASP
EasyPump II ST/LT
Epican
Scalpel
Hemostat
Perican Perican Hustead Perifix Perifix Hustead Accu Bloc
Establishment Types
Export Device to the United States But Perform No Other Operation on Device