FDA Registration
Inactive
🇲🇾 Malaysia
YCH Distripark Sdn Bhd
·
Expires 2026
Products
80
Proprietary Names
58
Establishment Types
1
Classifications
80
Registration Details
- Registration Name
- YCH Distripark Sdn Bhd
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 22203, Jalan Kemuning 33/52,, Taman Teknologi, Seksyen 33
- City
- Shah Alam Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K853014
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 St Ste 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 |
|---|---|---|---|---|---|
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2015-12-08 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2022-12-29 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-07-11 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-12-27 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2012-09-27 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2022-12-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2022-12-29 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2022-12-29 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2022-12-29 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2022-12-29 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2012-09-27 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2022-12-29 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2022-12-29 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-29 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2022-12-29 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2022-12-29 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2022-12-29 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2022-12-29 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2022-12-29 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2022-12-29 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2022-12-29 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2021-12-30 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 2022-12-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2022-12-29 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2022-12-29 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-12-29 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2022-12-27 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-12-27 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-12-27 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-12-27 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2022-12-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2022-12-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2022-12-29 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2022-12-29 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2022-12-29 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2013-11-28 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2022-12-29 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2022-12-29 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2022-12-29 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2022-12-29 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2022-12-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-12-29 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2019-07-18 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2022-12-29 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2022-12-29 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2022-12-29 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-12-27 |
Proprietary Names
Clamp
Infusion Set, Winged Infusion set
Aesculap
OmnicanFine
Introcan Safety 2
Knife
Epican
Rasp
Scaler
Forceps
Sterican
OPERATIVE EXCAVATOR
RONGEUR FORCEPS
Applier
Scissors
SURGICAL RASP
Retractor
Espocan, Espocan Tuohy
UTERINE CLAMP
ORTHOPEDIC CURETTE
Holder
SURGICAL CLIP APPLIER
Guide
Blade
Elevator
Serofine® Needles
Scisssors
Dissector
Orthopedic Instrument
INSTRUMENT SURGICAL GUIDE
Pencan
Spatula
PERIODONTIC KNIFE
Surgical Instrument
ORTHOPEDIC WIRE TWISTER
Hemostat
Speculum
Introcan Safety 3
PERIODONTIC PROBE
Pencan and Spinocan Spinal Introducer Needles
Extractor
METAL TONGUE DEPRESSOR ENT
Handle
Perifix, Perifix Pediatric
Introcan Safety
Hook
EasyPump II ST/LT
Spinocan
Perifix Perifix Tuohy Non-Winged Tuohy Perican Tuohy
Depressor
Introcan Safety 2 (multi)
BIOPSY FORCEPS
SURGICAL DENTAL ELEVATOR
Curette
SurecanSafety II
Scalpel
AESCULAP
Perican Perican Hustead Perifix Perifix Hustead Accu Bloc
Establishment Types
Export Device to the United States But Perform No Other Operation on Device