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
Phone
424 2718169

Products

Device Name Product Code
Curette HTF
Introducer, Catheter DYB
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Remover, Crown EIS
Forceps, Dressing, Dental EFL
Condenser, Amalgam And Foil, Operative EKG
Needle, Hypodermic, Single Lumen FMI
Probe, Periodontic EIX
Clamp HXD
Guide, Surgical, Instrument FZX
Handle, Scalpel GDZ
Anesthesia Conduction Kit CAZ
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Retractor, All Types EIG
Plugger, Root Canal, Endodontic EKR
Forceps, Biopsy, Gynecological HFB
Blade, Scalpel GES
Hook, Tracheal KCH
Clamp, Surgical, General & Plastic Surgery GDJ
Curette, Surgical, General Use FZS
Laparoscope, General & Plastic Surgery GCJ
Clamp, Vascular DXC
Explorer, Operative EKB
Scaler, Periodontic EMN
Retractor, Self-Retaining FFO
Handle, Instrument, Dental EJB
Dissector, Surgical, General & Plastic Surgery GDI
Clamp, Non-Electrical FFN
Forceps, Wire Holding HYA
Elevator, Surgical, Dental EMJ
Orthopedic Manual Surgical Instrument LXH
Forceps, Ophthalmic HNR
Rasp HTR
Excavator, Dental, Operative EKC
Mirror, Mouth EAX
Instruments, Surgical, Cardiovascular DWS
Forceps, Rongeur, Surgical EMH
Holder, Needle; Orthopedic HXK
Speculum, Vaginal, Metal HDF
Scissors, General, Surgical LRW
Forceps, General & Plastic Surgery GEN
Applier, Staple, Surgical, GEF
Tissue Expander And Accessories LCJ
Scissors, Orthopedic, Surgical HRR
Instrument, Ligature Tucking, Orthodontic ECP
Elevator, Surgical, General & Plastic Surgery GEG
Instrument, Filling, Plastic, Dental EIY
Depressor, Tongue, Non-Surgical FMA
Carver, Wax, Dental EIK
Clamp, Uterine HGC
Retractor, Vaginal HDL
Hook, Surgical, General & Plastic Surgery GDG
Clamp, Umbilical HFW
Retractor, Ent KAL
Applier, Surgical, Clip GDO
Scissors, Ophthalmic HNF
Twister, Wire HXS
Forceps, Articulation Paper EFK
Knife, Periodontic EMO
Non-Coring (Huber) Needle PTI
Retractor GAD
Guide, Needle, Surgical GDF
Knife, Surgical EMF
Forceps HTD
Forceps, Tooth Extractor, Surgical EMG
Spatula, Surgical, General & Plastic Surgery GAF
Burnisher, Operative EKJ
Forceps, Ent KAE
Depressor, Metal Tongue, Surgical KBL
Punch, Surgical LRY
Scissors, Surgical Tissue, Dental EGN
Extractor HWB
Instruments, Dental Hand DZN
Rasp, Surgical, General & Plastic Surgery GAC
Pump, Infusion, Elastomeric MEB
Chisel, Osteotome, Surgical EMM
Scalpel, One-Piece GDX
Hemostat, Surgical EMD
Hemostat HRQ
Retractor, Non-Self-Retaining FGN
Holder, Needle, Gastroenterologic FHQ

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