FDA Registration
Active
🇲🇾 Malaysia
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
Reg #: 9612086
·
FEI: 3002806575
·
Expires 2026
Products
81
Proprietary Names
62
Establishment Types
2
Classifications
81
Registration Details
- Registration Name
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Registration Number
- 9612086
- FEI Number
- 3002806575
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BAYAN LEPAS FREE TRADE ZONE
- City
- PENANG Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Operator Number
- 8040308
- Address
- BAYAN LEPAS FREE TRADE ZONE, --
- City
- PENANG
- State
- MY-NOTA
- Postal Code
- --
- Country
- MY
- Correspondent
- Kamaal Anas
US Agent
- Business Name
- B. BRAUN MEDICAL, INC.
- Contact Name
- Kamaal Anas
- Address
- 824 Twelfth Avenue
- City
- Bethlehem
- State
- PA
- ZIP
- 18018
- Country
- US
- [email protected]
- Phone
- 484 5231349
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2020-12-18 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2020-12-18 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2012-11-28 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2020-12-18 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2017-11-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-12-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-04-22 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2012-11-28 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2020-12-18 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2012-11-28 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-02-23 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2020-12-18 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2020-12-18 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2025-12-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-12-18 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2020-12-18 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2020-12-18 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2012-11-28 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2020-12-18 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2017-12-05 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2017-12-05 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2022-05-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2013-08-08 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 2020-12-18 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2020-12-18 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2012-11-28 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2012-11-28 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2020-12-18 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 2020-12-18 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2020-12-18 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2020-12-18 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2022-12-08 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2020-12-18 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-11-28 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2020-12-18 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2012-11-28 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2012-11-28 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2020-12-18 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2020-12-18 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2012-11-28 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2012-11-28 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2020-12-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-12-08 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2022-12-08 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-11-28 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2020-12-18 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2012-11-28 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2012-11-28 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2012-11-28 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2012-11-28 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2012-11-28 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2020-12-18 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2012-11-28 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 2020-12-18 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2012-11-28 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2012-11-28 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2022-12-08 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2020-12-18 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2012-11-28 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2012-11-28 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2012-11-28 |
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
Orthopedic Wire Twister
Handle
Scissors
Spatula
Introcan Safety 3
Introcan Safety 2 (multi)
Pencan
Orthopedic Instrument
Retractor
Applier
Sterican
Omnican fine
EasyPump
Scalpel
Perifix
Perifix Pediatric
Periodontic Probe
Blade
Epican
Elevator
Rongeur Forceps
Extractor
Speculum
Introcan Safety 2 (multi) Deep Access
Dissector
Periodontic Knife
Guide
Surgical Dental Elevator
Perican
Perifix Hustead
Accu Bloc
Perican Hustead
Surgical Instrument
Surgical Rasp
Scaler
Pencan and Spinocan Spinal Introducer Needles
Holder
Operative Excavator
Non-winged Tuohy
Perican Tuohy
Perifix Tuohy
Uterine Clamp
Spinocan
Espocan Tuohy
Espocan
Knife
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)