Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010055973

FEI Number

3010055973

Entity Name

YCH DISTRIPARK SDN BHD

City/State/Country

Prai Pulau Pinang, MY

Establishment Address

Plot 201, Lorong Perusahaan Maju 9,, Taman Perindustrian Bukit Tengah, Prai Pulau Pinang 13600, MY

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

YCH Distripark Sdn Bhd (Owner Number: 10041986)

Owner / Operator Contact Address

Plot 201, Lorong Perusahaan Maju 9,, Taman Perindustrian Bukit Tengah, Prai, MY-07 14000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOPEDIC CURETTE Introcan Safety Aesculap Forceps Aesculap Sterican PERIODONTIC PROBE Introcan Safety 2 (multi) Clamp INSTRUMENT SURGICAL GUIDE Handle Pencan Retractor Aesculap BIOPSY FORCEPS Blade Hook Clamp Curette Introcan Safety 2 Aesculap Aesculap Scaler Retractor Handle Spinocan Dissector Clamp Forceps SURGICAL DENTAL ELEVATOR Orthopedic Instrument Forceps Rasp Sterican OPERATIVE EXCAVATOR Aesculap Surgical Instrument RONGEUR FORCEPS Holder Speculum Scisssors Forceps Applier Infusion Set, Winged Infusion set Scissors Aesculap Elevator Aesculap Depressor Aesculap UTERINE CLAMP Retractor Hook Aesculap Retractor SURGICAL CLIP APPLIER Scissors Perifix, Perifix Pediatric ORTHOPEDIC WIRE TWISTER AESCULAP PERIODONTIC KNIFE Serofine® Needles Perifix Perifix Tuohy Non-Winged Tuohy Perican Tuohy SurecanSafety II Retractor Guide OmnicanFine Knife Pencylcap Forceps Forceps Spatula Aesculap Forceps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2022-12-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-12-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-12-27
EIS	Remover, Crown	Dental	Class 1	872.4565	2022-12-29
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2022-12-29
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2022-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-11-28
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2022-12-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-12-27
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-12-29
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-12-29
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2019-07-17
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-07-17
EIG	Retractor, All Types	Dental	Class 1	872.4565	2022-12-29
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2022-12-29
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2022-12-29
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-12-29
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2022-12-29
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-12-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-12-27
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2022-12-27
EKB	Explorer, Operative	Dental	Class 1	872.4565	2022-12-29
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2022-12-29
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2022-12-29
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2022-12-29
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-09-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2022-12-29
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2022-12-29
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2022-12-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-12-29
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-12-29
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-09-27
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2022-12-29
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-12-29
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2022-12-29
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2022-12-29
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2022-12-29
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2022-12-29
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-12-29
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
GEF	Applier, Staple, Surgical,	General, Plastic Surgery	Class 1	878.4800	2022-12-29
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2015-12-08
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2022-12-29
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2022-12-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2022-12-29
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2022-12-29
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2022-12-29
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2022-12-29
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2022-12-29
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2022-12-29
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-12-29
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-12-29
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2022-12-29
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-27
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2022-12-29
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2022-12-29
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2022-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-06-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-09-27
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2019-07-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2022-12-29
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-07-11
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-12-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-03-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-12-29
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2022-12-29
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-12-29
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2022-12-29
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-12-29

Official Correspondent

Nurashikin Ahmad

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

YCH Distripark Sdn Bhd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010055973. Last updated year: 2026. Please use registration number 3010055973 when referencing this establishment in official correspondence.