Jianerkang Medical Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 18 device types, 2 products catalogued, 1 clearance.
Jianerkang Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bandage, Cast, Bandage, Elastic and 16 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2000.
Registration
| Registered name | JIANERKANG MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9616874 |
| FEI number | 3006403682 |
| DUNS | 530968767 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 健尔康医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91320413714946201R |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District |
| Postal code | 213251 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Anti Fog Solution And Accessories, Endoscopy | Class 2 | Anti fog solution and accessories, endoscopy | 2024 | 5 |
| Bandage, Cast | Class 1 | 2024 | 81 | |
| Bandage, Elastic | Class 1 | Elastic Bandage, Stretch Bandage | 2009 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | SurePrep Plus, Bandage, liquid, skin protectant | 2019 | 41 |
| Container, Specimen, Non-Sterile | Class 1 | Container, Specimen, NON-Sterile | 2024 | 115 |
| Dressing, Wound, Drug | Class U | 2024 | 48 | |
| Dressing, Wound, Occlusive | Class 1 | 2024 | 183 | |
| Fiber, Medical, Absorbent | Class 1 | Operating Room Towels, Absorbent Patient Underpad, OR Towel Sterile OR NON Sterile, Gauze Sponge, NON Woven Sponge, OR Towel, Surgical Towel | 2004 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; gauze sponge; Gauze Swabs 100% Cotton, Absorbent Gauze Roll 100% cotton; Burn Pad; Cotton Ball; Dental Roll 100% cotton; Dressing Pack for Heavy Drainage;, Gauze sponge, gauze swab, non woven sponge, conforming bandage, fluffy gauze bandage roll, fluffy gauze spong | 2002 | 266 |
| Gauze/Sponge, Internal | Class U | 2025 | 8 | |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Lap Sponge – X-ray detectable, LAP Sponge With X-RAY, Hermatige Hospital PRO, LAP Sponge | 2000 | 67 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | Aquapak Prefilled Humidifier, AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif, Humidifier, Respiratory Gas, (Direct Patient Interface) | 2025 | 12 |
| Lubricant, Patient | Class 1 | Sterile Lubricating Jelly, Lubricant Patient | 2012 | 33 |
| Media, Coupling, Ultrasound | Class 2 | Sterile and Non-Sterile Ultrasound Gels; Media, Coupling, Ultrasound | 2024 | 8 |
| Solvent, Adhesive Tape | Class 1 | Remover Adhesive Tape | 2018 | 20 |
| Tape And Bandage, Adhesive | Class 1 | 2024 | 353 | |
| Tray, Surgical, Instrument | Class 1 | 2015 | 105 | |
| Tubing, Noninvasive | Class 2 | Connecting tube, suction tubing, connecting tube | 2021 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| EndoGlide+™ | KMJ | 8 |
| Boston Scientific | NAB | 3 |
Clearances
1 clearance names Jianerkang Medical Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232957 | 2023-12-15 | MUI | Traditional | This company |
| K112110 | 2012-04-10 | KMJ | Traditional | Jianerkang Medical Dressing Company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Employees | 1600+ |
| Factory area | 35000 m² |
| Main products | Surgical supplies, Wound care, Infection control, Cleaning and disinfection, Non-woven fabrics |
| Certifications | China GMP, ISO certifications, Shanghai Stock Exchange listed (603205) |
| Export markets | Americas, EU, Asia, Middle East, Africa; 10,000+ medical institutions globally |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.