FDA Registration
Active
🇭🇰 Hong Kong
HONG KONG LUTE TECHNOLOGY CO., LIMITED
Reg #: 3027605322
·
FEI: 3027605322
·
Expires 2026
Products
27
Proprietary Names
49
Establishment Types
4
Classifications
27
Registration Details
- Registration Name
- HONG KONG LUTE TECHNOLOGY CO., LIMITED
- Registration Number
- 3027605322
- FEI Number
- 3027605322
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 803B, 8/F, West Bund International Building, 290-296 Yuen Chau Street, Cheung Sha Wan, Kowloon
- City
- HONG KONG
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K223693
Owner / Operator
- Firm Name
- HONG KONG LUTE TECHNOLOGY CO., LIMITED
- Operator Number
- 10088201
- Address
- Room 803B, 8/F, West Bund International Building, 290-296 Yuen Chau Street, Cheung Sha Wan, Kowloon
- City
- HONG KONG
- State
- HK-NOTA
- Postal Code
- 000000
- Country
- HK
- Correspondent
- Athena Pan
US Agent
- Business Name
- ROOT TECHNOLOGY LTD.
- Contact Name
- Amy Dong
- Address
- 1580 N Logan St Ste 660 #30327
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 424 5137016
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2023-06-08 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2023-11-15 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2023-11-15 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-12-25 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | Class 1 | General Hospital | No | 2023-11-15 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2026-02-25 |
| Douche Apparatus, Vaginal, Therapeutic | HED | Class 1 | Obstetrics/Gynecology | No | 2023-11-15 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2023-11-15 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2024-01-26 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2026-01-07 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-04-21 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2025-09-25 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2024-03-22 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-11-15 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2024-03-22 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2024-05-06 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2026-04-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-11-15 |
| Ring, Teething, Fluid-Filled | KKO | Class 2 | Dental | No | 2024-04-17 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-11-15 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2023-11-15 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2024-05-13 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-11-15 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2023-11-15 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-11-15 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-11-15 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2024-03-27 |
Proprietary Names
Momcozy Wearable Breast Pump (Model M5);
Hydrogel Breast Pads, Model BF009
Momcozy Baby Electric Nasal Aspirator, BN02
Electric Baby Nasal Aspirator - BN006
Nursing pads
Disposable nursing pads
Wearable Breast Pump (Model P3);
MeggO Maternity Ball (Model: MeggO)
Wearable Breast Pump (Model P10); Wearable Breast Pump (Model Y10);
Peri bottle, PK003
Breast Warmers, BF007
Instant Cold Soothing Pad, PK004
Momcozy Maternity Belt, YB001
Cold Soothing Ice Pad - PK008
Momcozy Colostrum Collector - BC002
Tongue brush suit - MCTB01
Wearable Breast Pump (Model R12);
Momcozy Lactation Massager - A1Pro
Momcozy Lactation Massager - LA01
Momcozy Lactation Massager - A1
Momcozy Lactation Massager
Momcozy Lactation Massager - LM01, LM02, LM03, LM04
Momcozy Breast care set - BF020
360° silicone toothbrush - MCST01
Baby 2-in-1 Nasal Aspirator with Sprayer - BN005
Baby Nasal Aspirator (Model BN02)
Baby Medicine Dispenser
Momcozy Wearable Breast Pump (Model S9 Pro); Momcozy Wearable Breast Pump (Model S12 Pro);
Hand Teether - BY005 BY006 BY007
Water-fillable Icy Teethers - BY001
Momcozy Wearable Breast Pump (BP137, BP141)
Wearable Breast Pump (Model S10)
Baby Oral Cleaner, Model MCBOC01
Momcozy precise-pick postpartum recovery kit and Nursing kit, PK002
Momcozy Postpartum Basic Recovery Kit (PK007)
Momcozy Free-move-new-thin disposable period underwear (PK006)
Momcozy precise-pick postpartum recovery kit, PK001
Momcozy Nipple Shield - NS-001
Momcozy Nipple Protective Cups - NS005
Finger Cover Shields, Model MCBOC02
Momcozy Baby Diapers, Baby Diapers Natural bamboo Diapers - BD05
Momcozy Baby Diapers - B01, B03
360° Fit Bouncy Soft Training Pants - B04
Hot and Cold Breast Pads, Model BF008
Memory foam nursing pillow,Model NP006 NP007
Wet wipes, disposable wet wipes, alcohol wet wipes, cotton wet wipes, toilet wet wipes
Baby wipes, hand wipes, tableware wipes, disinfectant wet wipes, feminine wet wipes
Breast pump wipes, BD03
Maternity Compression Socks-SO014, BambooFlex 3-in-1 Compression Socks-SO016
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Foreign Private Label Distributor
Manufacture Medical Device