FDA Registration
Active
🇨🇳 China
JIANGSU HANHENG MEDICAL TECHNOLOGY CO., LTD
Reg #: 3016159368
·
FEI: 3016159368
·
Expires 2026
Products
20
Proprietary Names
44
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- JIANGSU HANHENG MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3016159368
- FEI Number
- 3016159368
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #118 Xinyuan 3rd Road, Xinbei District
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Jiangsu HanHeng Medical Technology Co., Ltd
- Operator Number
- 10061791
- Address
- #118 Xinyuan 3rd Road, Xinbei District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213031
- Country
- CN
- Correspondent
- Yueming Xia
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 |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2026-04-27 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2019-11-20 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-11-20 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2020-03-23 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2019-11-20 |
| Drape, Surgical, Ent | ERY | Class 2 | General, Plastic Surgery | No | 2019-11-20 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2025-08-28 |
| Applicator For Rectal Suppository | OOW | Class 1 | Gastroenterology, Urology | No | 2019-11-20 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Emergency Obstetrical Kit | OKU | Class 1 | Obstetrics/Gynecology | No | 2019-11-20 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2019-11-20 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2019-11-20 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2019-11-20 |
| Connector, Ureteral Catheter | EYK | Class 1 | Gastroenterology, Urology | No | 2019-11-20 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2019-11-20 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2019-11-20 |
| Catheter, Ventricular, General & Plastic Surgery | GBS | Class 1 | General, Plastic Surgery | No | 2019-11-20 |
Proprietary Names
A-0116, A-0117, A-0118, A-0119, A-0120, A-0121, A-02, A-03, A-04, A-04-50, A-04-65, A-04-70, A-04-75, A-04-80, A-04-85,
Disposable Sampling Swab (non-sterile): A-01, A-01-30, A-01-50, A-01-65, A-01-70, A-01-75, A-01-80, A-01-91, A-010,
G-012, G-013, G-014, G-014-30, G-014-40, G-014-50, G-014-60, G-014-70, G-014-80, G-015, G-015-7621C, G-015-2193C, G-016,
G-0131, G-0132, G-0133, G-0134, G-0135, G-0136, G-0137, G-0138, G-02, G-020, G-016-60, G-016-70, G-016-80, G-017, G-018,
G-08, G-080, G-081, G-082, G-09, G-090, G-091, G-092, G-11, ZCY-03, ZCY-04
G-032, G-04, G-040, G-041, G-042, G-05, G-050, G-051, G-052, G-06, G-060, G-061, G-062, G-063, G-064, G-065, G-066,
A-04-91, A-04-95, A-04-100, A-040-12, A-041, A-042, A-05, A-06, A-07, A-08, A-09, A-10, A-11, A-12, A-13, B, C, C-01,
G-067, G-068, G-069, G-0610, G-0611, G-0612, G-0613, G-0614, G-0615, G-0616, G-0617, G-0618, G-07, G-070, G-071, G-072,
G-019, G-0110, G-0111, G-0112, G-0113, G-0114, G-0115, G-0116, G-0117, G-0118, G-0119, G-021, G-022, G-03, G-030, G-031,
A-010-75, A-011, A-012, A-013, A-014, A-015, A-016, A-017, A-018, A-019, A-0110, A-0111, A-0112, A-0113, A-0114, A-0115,
C-010, C-02, C-03, C-030, C-031, C-032, C-04, C-040, C-041, C-042, C-05, C-050, C-051, C-052, D, D-01, D-02, D-03,
G-016-30, G-016-40, G-016-50, G-0120, G-0121, G-0122, G-0123, G-0124, G-0125, G-0126, G-0127, G-0128, G-0129, G-0130,
E, E-01, E-02, E-03, E-000, E-010, E-020, E-030, F, F-01, F-02, F-03, F-000, F-010, F-020, F-030, G-01, G-010, G-011,
Disposable Sampling spoon
Disposable urine drainage bags
Disposable Virus Sampling Swab Kit
Disposable suction catheter,Disposable suction connecting tubes with Yankauer
Disposable medical pad
Steradian Sheild
Disposable rectal tube
Disposable mucus extrators
Disposable Amniotic hook
Disposable Endometrial Sampling Kit
Disposable I.D. bracelet
Disposable nasal oxygen cannula
Disposable medical gloves
Disposable vaginal expander
Disposable nelaton catheter
Disposable Umbilical Cord Clamp
Medical hand wash brush
ZCY-03; ZCY-04)
Disposable Sterile Sampling Brush, Disposable Sterile Cervical Sampler, Disposable Sterile Scraper
Disposable Sampling Swab (A-01;A-01-30;A-01-50;A-01-65;A-01-70;A-01-75;A-01-80;A-01-91;A-010;A-010-75;A-011;A-012;
G-011;G-012;G-013;G-014;G-014-30;G-014-40;G-014-50;G-014-60;G-014-70;G-014-80;G-015;G-016;G-016-30;G-016-40;G-016-50;
G-021;G-022;G-03;G-030;G-031;G-032;G-04;G-040;G-041;G-042;G-05;G-050;G-051;G-052;G-06;G-060;G-061;G-062;G-063;G-064;
C-052;D;D-01;D-02;D-03;E;E-01;E-02;E-03;E-000;E-010;E-020;E-030;F;F-01;F-02;F-03;F-000;F-010;F-020;F-030;G-01;G-010;
G-0120;G-0121;G-0122;G-0123;G-0124;G-0125;G-0126;G-0127;G-0128;G-0129;G-0130;G-0131;G-0132;G-0133;G-0134;G-02;G-020;
A-02;A-03;A-04;A-04-50;A-04-65;A-04-70;A-04-75;A-04-80;A-04-85;A-04-91;A-04-95;A-04-100;A-040-12;A-041;A-042;A-05;A-06;
A-013;A-014;A-015;A-016;A-017;A-018;A-019;A-0110;A-0111;A-0112;A-0113;A-0114;A-0115;A-0116;A-0117;A-0118;
G-08;G-080;G-081;G-082;G-09;G-090;G-091; G-092; A-0119; A-0120; A-0121; A-13; G-0135; G-0136; G-0137; G-0138; G-11;
G-065;G-066;G-067;G-068;G-069;G-0610;G-0611;G-0612;G-0613;G-0614;G-0615;G-0616;G-0617;G-0618;G-07;G-070;G-071;G-072;
G-016-60;G-016-70;G-016-80;G-017;G-018;G-019;G-0110;G-0111;G-0112;G-0113;G-0114;G-0115;G-0116;G-0117;G-0118;G-0119;
A-07;A-08;A-09;A-10;A-11;A-12;B;C;C-01;C-010;C-02;C-03;C-030;C-031;C-032;C-04;C-040;C-041;C-042;C-05;C-050;C-051;
Disposable feeding tube, Disposable stomach tube
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)