Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612086

FEI Number

3002806575

Entity Name

B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

City/State/Country

PENANG Pulau Pinang, MY

Establishment Address

BAYAN LEPAS FREE TRADE ZONE, PENANG Pulau Pinang --, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

B. BRAUN MEDICAL INDUSTRIES SDN. BHD. (Owner Number: 8040308)

Owner / Operator Contact Address

BAYAN LEPAS FREE TRADE ZONE, --, PENANG, MY-NOTA --, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthopedic Curette Metal Tongue Depressor ENT Tongue Depressor Biopsy Forceps Surecan Safety II Instrument Surgical Guide Pencylcap Forceps Surgical Clip Applier Hemostat Introcan Safety 2 Clamp Aesculap Hook Curette Rasp Aesculap Aesculap Aesculap Orthopedic Wire Twister Hemostat Handle Scissors Spatula Aesculap Introcan Safety 3 Forceps Introcan Safety 2 (multi) Forceps Aesculap Pencan Orthopedic Instrument Retractor Applier Sterican Omnican fine EasyPump Scalpel Perifix Perifix Pediatric Periodontic Probe Forceps Aesculap Clamp Scissors Forceps Blade Aesculap Aesculap Epican Elevator Aesculap Rongeur Forceps Aesculap Aesculap Extractor Aesculap Speculum Introcan Safety 2 (multi) Deep Access Retractor Dissector Aesculap Periodontic Knife Guide Forceps Retractor Surgical Dental Elevator Perican Perifix Hustead Accu Bloc Perican Hustead Perifix Aesculap Surgical Instrument Surgical Rasp Scaler Pencan and Spinocan Spinal Introducer Needles Hook Holder Sterican

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2020-12-18
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2020-12-18
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2012-11-28
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2020-12-18
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2017-11-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-12-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-22
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2012-11-28
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2020-12-18
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2012-11-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-02-23
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2020-12-18
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-11-28
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2020-12-18
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2025-12-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2020-12-18
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2020-12-18
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2012-11-28
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-11-28
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-28
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2020-12-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2021-12-13
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-11-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-07-29
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-11-28
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2020-12-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2017-12-05
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2017-12-05
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-11-28
GEF	Applier, Staple, Surgical,	General, Plastic Surgery	Class 1	878.4800	2012-11-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-09-07
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2013-08-08
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-11-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-07
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2020-12-18
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2020-12-18
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2012-11-28
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2012-11-28
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2012-11-28
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EIS	Remover, Crown	Dental	Class 1	872.4565	2020-12-18
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2020-12-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2011-11-15
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2020-12-18
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2020-12-18
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2022-12-08
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2020-12-18
HWB	Extractor	Orthopedic	Class 1	888.4540	2012-11-28
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2020-12-18
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2012-11-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-08-29
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2012-11-28
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-28
EKB	Explorer, Operative	Dental	Class 1	872.4565	2020-12-18
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2020-12-18
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-28
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-11-28
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-11-28
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2020-12-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-12-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-12-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2022-12-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-11-28
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-12-18
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2012-11-28
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2012-05-02
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2012-11-28
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2012-11-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-03

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612086. Last updated year: 2026. Please use registration number 9612086 when referencing this establishment in official correspondence.