Data / Medical devices / Hong Kong / Hong Kong Lute Technology Co., Limited
Hong Kong Lute Technology Co., Limited: FDA-registered device maker in Hong Kong, Hong Kong, 8 510(k) clearances
Hong Kong Lute Technology Co., Limited is registered with the FDA (registration 3027605322) in Hong Kong, Hong Kong. It lists 27 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027605322
- Address
- Room 803B, 8/F, West Bund International Building, Yuen Chau Street, Cheung Sha Wan, Kowloon, Hong Kong, Hong Kong, 000000
- Owner or operator
- HONG KONG LUTE TECHNOLOGY CO., LIMITED (10088201)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- June 8, 2023
- Registered through
- 2026
- Brand names listed
- 360° Fit Bouncy Soft Training Pants - B04, 360° silicone toothbrush - MCST01, Baby 2-in-1 Nasal Aspirator with Sprayer - BN005, Baby Medicine Dispenser, Baby Nasal Aspirator (Model BN02), Baby Oral Cleaner, Model MCBOC01, Baby wipes, hand wipes, tableware wipes, disinfectant wet wipes, feminine wet wipes, Breast Warmers, BF007 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Breast Pump Kit | OHH | 2 | Manufacturer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Foreign private label distributor | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | BTA | Substantially Equivalent | Shenzhen Desida Technology Co., Ltd. | accessdata.fda.gov |
| March 6, 2024 | K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | HGX | Substantially Equivalent | Shenzhen Root Innovation Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2023 | K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2023 | K223693 | Electric breast pump (model: M5) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
| January 13, 2023 | K222782 | Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) | HGX | Substantially Equivalent | Zhejiang Carebao Co., Ltd. | accessdata.fda.gov |
| June 27, 2022 | K220309 | Wearable Breast Pump (Model S10) | HGX | Substantially Equivalent | Shenzhen Lutejiacheng Technology Co., Ltd. | accessdata.fda.gov |
| February 11, 2022 | K211024 | Electric Breast Pump | HGX | Substantially Equivalent | Shantou Huihengqi Electronic Technology Co., Ltd. | accessdata.fda.gov |
| May 6, 2015 | K143585 | Electric Breast Pump | HGX | Substantially Equivalent | Shantou Xinghe Electrical Apparatuses Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Menstrual, Unscented
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Scraper, Tongue
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Garment, Protective, For Incontinence
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.