FDA Registration
Active
🇨🇳 China
JCMED TIANJIN IMPORT AND EXPORT CO., LTD
Reg #: 3015821396
·
FEI: 3015821396
·
Expires 2026
Products
51
Proprietary Names
53
Establishment Types
2
Classifications
51
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Registration Details
- Registration Name
- JCMED TIANJIN IMPORT AND EXPORT CO., LTD
- Registration Number
- 3015821396
- FEI Number
- 3015821396
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone
- City
- Tianjin
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192478
Owner / Operator
- Firm Name
- JcMed TIANJIN Import and Export Co., Ltd
- Operator Number
- 10081379
- Address
- 418-419 Room, Yuanhang Business Center, Lucia Commercial Street, Airport Economic Zone
- City
- Tianjin
- State
- CN-TJ
- Postal Code
- 300300
- Country
- CN
- Correspondent
- Allan Zhang
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 |
|---|---|---|---|---|---|
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2025-07-08 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-04-15 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2025-07-08 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2022-05-18 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-07-08 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2025-07-08 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2022-05-18 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-07-08 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2025-12-12 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2025-07-08 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2025-07-17 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2021-04-08 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-08-26 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2025-07-08 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2025-07-08 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2025-07-08 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2025-07-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-04-15 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2025-07-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-12-12 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2025-07-08 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-09-12 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2022-05-18 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2023-09-12 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2025-07-08 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2023-09-12 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2025-07-08 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2023-09-12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-05-18 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-05-18 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2021-04-15 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-07-17 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2025-12-12 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2025-07-08 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-12-12 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2025-12-12 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2025-07-08 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2025-07-08 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2025-07-17 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2021-04-15 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2025-07-08 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2022-05-18 |
Proprietary Names
Venturi mask
Cotton Tape; Silicone Tape; Foam Tape; PU tape; Muscle Tape; Adhesive Bandage; Skin Closure Strips; Surgical Tape;
PE Tape; Non-woven Tape; Silk Tape; Spunlaced Non-woven Tape; Fixing Tape; Zinc-oxide Tape; Tapes; Adhesive Tape;
Medical Tape; Kinesio Tape; Kinesiology Tape; Muscle Tape; Sports Tape; Elastic Tape
Oropharyngeal Airway
Amorphous Hydrogel Dressing; Burn Dressing; Hydrogel Gauze; Hydrogel Medical Dressing
Alginate with Silver Dressing
Cannula
Foam Dressing; Honey Gauze Dressing; Oil Emulsion Dressing; Petrolatum Dressing; Silicone Foam Dressing;
Nonwoven Wound Dressing; Super Absorbency Dressing; Silicone Wound Contact Dressing; Silicone Dressing Scarcin Pad;
Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Silicone Dressing; NPWT Dressing
Silicone Gel Scar Dressing; Silicone Gel Sheet; Gelling Fiber Dressing; Chest Seal; Transparent Dressing;
Nasal oxygen
Wound Dressing Kit
Breathing Exerciser; Lung Trainer; One Ball Spirometer; Respiratory Excerciser; Respiratory Meter;Three Balls Spirometer
Radiographic protective glove - Gloves
Wound Closure Device
Tourniquet
Ear wash ball
Nebulizer kit
Nasal irrigator
Chest Drainage Catheter
Adhesive Wound Dressing; Sterile Gauze Pad; ABD Pad; Non-Adherent Wound Pad; Gauze Roll; Gauze Swab;
Gauze Bandage; Absorbent Pad; Combine Pad; Gauze Sponge; Non Adherent/Wound Dressing Pad; Foam Pad;
Soluble Hemostatic Gauze; Gauze Ball
Oxygen mask
Saliva Collection
Endotracheal Tube, Catheter Fixation Kit
Alginate dressing, Foam Dressing Set, Hydrophilic Dressing, Wound Plaster, Non Woven Dressing, Foam Dressing, Acne Patc
First Aid Kit
Urine Drainage Bag, Urine Collector, Urine Bag, Plastic Parts, Urine Bag And Accessories, Catheter Valve, Extension Tube
Surgical drape
Catheter Valve, Extension Tube
Disposable Use of Drainage Bag, Non-Sterile Urine Collection Bag, leg bag (urine), Leg Bags And Accessories,
Skin protector paster, Hydrocolloid skin barrier, Skin protective power, Anti-leakage strip,
Hydrocolloid skin protective ring
First aid kit with drug
Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx
Cold Bandage; Elastic Bandage; Cohesive Bandage; Conforming Bandage; Pet Bandage; Horse Bandage;
Self-Adhesive Bandage; Elastic Adhesive Bandage; Tubular Bandage; EAB Bandage; Net Bandage
First Aid Bandage; Latex Free Bandage; Latex Free Elastic Bandage; Medical Elastic Bandage; PBT Bandage;
BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free
Nasal Dressing
Ostomy bags
Silver Carbon dressing
I.V. CATHETER DRESSING
Silicone Scar Sheet
Surgical brush
Enema bag, Enema ball
Alcohol Prep Pad
Sharp Container
No sting barrier film spray, BANDAGE, LIQUID, SKIN PROTECTANT
Pack Hot or Cold Reusable
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device