FDA Registration
Active
🇲🇾 Malaysia
HOSPITECH MANUFACTURING SERVICES SDN BHD
Reg #: 3003528228
·
FEI: 3003528228
·
Expires 2026
Products
30
Proprietary Names
30
Establishment Types
1
Classifications
30
Registration Details
- Registration Name
- HOSPITECH MANUFACTURING SERVICES SDN BHD
- Registration Number
- 3003528228
- FEI Number
- 3003528228
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sub Lot 1, Lot 6536, Batu 6, Jalan Bukit Kemuning, Seksyen 34
- City
- Shah Alam Selangor
- Country
- MY
Owner / Operator
- Firm Name
- Hospitech Manufacturing Services Sdn Bhd
- Operator Number
- 10095153
- Address
- Sub Lot 1, Lot 6536, Batu 6, Jalan Bukit Kemuning, Seksyen 34
- City
- Shah Alam
- State
- Selangor
- Postal Code
- 40460
- Country
- MY
- Correspondent
- Desmond Wong
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2026-01-29 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2026-01-29 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2026-01-29 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2026-01-29 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2026-01-29 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2026-01-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2026-01-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2026-01-29 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2026-01-29 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2026-01-29 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2026-01-29 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2026-01-29 |
| Urinal | FNP | Class 1 | General Hospital | No | 2026-01-29 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2026-01-29 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2026-01-29 |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2026-01-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2026-01-29 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2026-01-29 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2026-01-29 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2026-01-29 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2026-01-29 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2026-01-29 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2026-01-29 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2026-01-29 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2026-01-29 |
Proprietary Names
DRAINAGE BOTTLE
SURGICAL CONNECTING TUBE
BLOOD TAKING SET
URIDROP
OXYGEN NASAL CANNULA
CLOSED SUCTION CATHETER, MUCUS EXTRACTOR
HIGH CONCENTRATION MASK
STERIPAD DRESSING PACK, ETT SET
ALCOHOL SWAB
NEEDLE HOLDER
OXYGEN MASK, TRACHEOSTOMY MASK
SWABBING SET
AMNIOTIC HOOK
RENAL DRESSING SET, INJECTION SET, HAEMO DRESSING PACK - 1F (6G6GB), BASIC DRESSING SET-BDS
INTUBATION STYLET
MALE & FEMALE URINAL, UNISEX URINAL
PRE PACK OBSTETRICS TUBING WITH Y-CONNECTOR
SUTURE REMOVAL SET
UMBILICAL CORD CLAMP
DISPOSABLE ANAESTHETIC BREATHING CIRCUITS
URINE COLLECTOR
SUCTION SET, SUCTION CATHETER, SUCTION YANKAUER
VENTURI MASK
HAEMO DRESSING PACK
FEMALE CATHETER
NEBULIZER MASK
STERILE TROCAR FOR SINGLE USE
VAGINAL SPECULUM
OXYGEN NIPPLE
URINE METER
Establishment Types
Manufacture Medical Device