FDA Registration
Active
🇲🇾 Malaysia
K-One MediTech Sdn. Bhd
Reg #: 3014747754
·
FEI: 3014747754
·
Expires 2026
Products
15
Proprietary Names
22
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- K-One MediTech Sdn. Bhd
- Registration Number
- 3014747754
- FEI Number
- 3014747754
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 68, Lengkok Rishah 2, Kawasan Perindustrian Silibin
- City
- Ipoh Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K170651
Owner / Operator
- Firm Name
- K-One MediTech Sdn. Bhd
- Operator Number
- 10058595
- Address
- 68, Lengkok Rishah 2, Kawasan Perindustrian Silibin
- City
- Ipoh
- State
- Perak
- Postal Code
- 30100
- Country
- MY
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2021-06-30 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2021-02-04 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2024-11-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-12-17 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-09-17 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-09-17 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-09-17 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2022-08-08 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2021-06-15 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2018-10-12 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2025-11-17 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2021-06-30 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2025-11-17 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | Class 1 | Anesthesiology | No | 2021-07-09 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2025-04-10 |
Proprietary Names
70352AZ- Weekly Pill Organizer Pill Box Rainbow
Ezy Dose Medtime Planner 67706
Ezy Dose Pill Planner Weekly AM/PM with easy fill 67705
70353AZ-AM/PM Pill Planner Rainbow
Ezy Dose Pill Planner Weekly with easy-fill 67704
Ezy Dose Pill Planner 67010
67010AMT3 WKLY AM/PM PILL PLNR 1/72
70352RA Rite Aid Weekly Pill Organizer PB RB 36/36
67705WG3 WG EASY FILL WKLY AM/PM 72/72
HK67010A WKLY AM/PM PILL PLNR 6/72
Steradian Shield
F414-436WM1 EQ First Aid Covers 6/24
Flent's Finger Cover: F414-405, F414-436, 69626
97203 Finger Covers-LG 6/72, F414-436WM EQ First Aid Covers 6/24
95858A FLENTS CLOTH ICE BAG LG 12/12
70551BKAMZ1 HEAR HUSH HOOPS BLACK 1/72
70551WG WG SILICONE EAR PLUGS 36/36
70551A HEAR HUSH HOOPS 3/18
Anaesthetic Breathing Circuit
EQ-BM-PS-001B ORIGINAL PILL SPLITTER (V1) 6/36, EQ-PS-001B ORIGINAL PILL SPLITTER (V1) 1/72
EQ-BM-PS-002A CENTERING PILL CUTTER (V2) 6/36
EQ-PS-002A CENTERING PILL CUTTER 1/72
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)