FDA Registration
Active
🇨🇳 China
SYNTHETAH, LLC
Reg #: 3041329419
·
FEI: 3041329419
·
Expires 2026
Products
14
Proprietary Names
24
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- SYNTHETAH, LLC
- Registration Number
- 3041329419
- FEI Number
- 3041329419
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SUITE 901, NO.3255 ZHOUJIAZUI BLVD
- City
- SHANGHAI
- Country
- CN
Owner / Operator
- Firm Name
- SYNTHETAH, LLC
- Operator Number
- 10094836
- Address
- SUITE 901, NO.3255 ZHOUJIAZUI BLVD
- City
- SHANGHAI
- State
- CN-NOTA
- Postal Code
- 200093
- Country
- CN
- Correspondent
- Kaia Zhu
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 |
|---|---|---|---|---|---|
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2025-12-28 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2025-12-28 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-12-28 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2025-12-28 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2025-12-28 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2025-12-28 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-12-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-12-28 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-12-28 |
Proprietary Names
ADHESIVE REMOVER SPRAY
DRESSING PAD COMBINED ABSORBENT, DRY WIPES, GAUZE SPONGE, GAUZE SWABS 100% COTTON, CONFORMING BANDAGE,
ABSORBENT GAUZE ROLL 100% COTTON, BURN PAD, COTTON BALL, DENTAL ROLL 100% COTTON, DRESSING PACK FOR HEAVY DRAINAGE,
FLUFFY GAUZE BANDAGE ROLL, FLUFFY GAUZE SPONGE
OSTOMY BAG
FOLEY CATHETER HOLDER
SILICONE GEL SCAR DRESSING, SILICONE GEL SHEET
BURN BLANKET
HYDROGEL SHEET DRESSING, AMORPHOUS HYDROGEL WOUND DRESSING, HYDROGEL IMPREGNATED DRESSING, BURN DRESSING, BURN GEL,
LUBRICANT PATIENT, STERILE LUBRICATING JELLY
ELASTIC BANDAGE, STRETCH BANDAGE
ALCOHOL PREP PAD
DISPOSABLE UNDERPAD, PROTECTIVE UNDERWEAR, BRIEFS, PULL-UPS, DIAPERS
HYDROCONDUCTIVE DRESSING, CALCIUM ALGINATE DRESSING, GELLING FIBER DRESSING, SUPER ABSORBENT DRESSING,
BORDERED GAUZE DRESSING, WATERPROOF COMPOSITE DRESSING, ACTIVATED CHARCOAL DRESSING, CARBON FIBER DRESSING
CLEANSING WIPES, WET WIPES
CLOTH TAPE, PAPER TAPE, SILICONE TAPE
NON-WOVEN RETENTION TAPE, REINFORCED IV TRANSPARENT DRESSING, SHOWER PROTECTOR, SKIN CLOSURE STRIPS, TRANSPARENT TAPE,
MANUKA HONEY HYDROCOLLOID DRESSING, MANUKA HONEY FOAM DRESSING, MANUKA HONEY GELLING FIBER DRESSING,
TRANSPARENT FILM DRESSING, MANUKA HONEY NON-ADHERENT DRESSING
FOAM DRESSING, SILICONE FOAM DRESSING, SILICONE SUPER ABSORBENT DRESSING, SILICONE WOUND CONTACT LAYER DRESSING,
WATERPROOF BORDERED FOAM DRESSING, HYDROCOLLOID FOAM DRESSING, HYDROCOLLOID DRESSING,
MANUKA HONEY CALCIUM ALGINATE DRESSING, MANUKA HONEY GEL, MANUKA HONEY HYDROGEL DRESSING,
NON-ADHERENT DRESSING, PETROLATUM DRESSING, OIL EMULSION IMPREGNATED DRESSING, XEROFORM PETROLATUM DRESSING,
Establishment Types
Export Device to the United States But Perform No Other Operation on Device