Pure Medical Grade Cotton Wool Used for Wound Cleaning and Care

Product Description

1. Company Profile 

Since 1990 our company was established and put into production we mainly produced products include Gauze 

Swabs(Sponges), Lap(Abdominal) Sponges, Non-woven Swabs(Sponges), Bandages, Absorbent Gauze, Absorbent 

Cotton, Cotton Filled(Dental) Sponges, Surgical Face Mask, Tongue depressor, Dressing, adhesive bandage, 

adhesive tape, cotton applicator, glove, Disposable Non-woven Wearing, sleeve and so on. Most of our products 

been exported to Europe Union market, North America market and Southeast Asia market and enjoy a well earned 

reputation for overall reliability in quality. We can do product testing independently according to EP, USP standard or 

other international standards, meanwhile we have our own testing laboratory that can test the physical and chemical 

indicators of the products, as well as Microorganism. In 2005, we got the certificate of EN ISO13485 form TUV 

Products Service GmbH, Germany. We can assure you the higher and more stable quality by our strict QA/QC 

systems. 

2. Manufacturer and European Representative 

2.1. Manufacturer: 

Hubei Qianjiang Kingphar Medical Material Co., Ltd. 

Yuanguang Road, 433100 Qianjiang, PEOPLE'S REPUBLIC OF CHINA 

 

 

 

SRN: CN-MF-000009051 

2.2. European Representative: 

Shanghai International Holding Corp. GmbH (Europe) 

Eiffestrasse 80, 20537 Hamburg, Germany 

SRN: DE-AR-000000001 

3. Product description 

3.1. Products Name: Non-woven sponges 

3.2. Model Number: NWS-G30-I, NWS-G40-II, NWS-G46-I 

3.3. EMDN Code: M0202030102 

3.4. The UDI System 

We have established a unique device identification (UDI) system to explicitly identify equipment in the global supply 

chain according to the regulation MDR Annex VI. 

BASIC UDI-DI:694878811002PQ 

3.5. Intended Purpose 

Non-woven sponges, non-sterile are ideally used for primary care of acute wounds, for the absorption of blood and 

exudate and for cleansing the skin's surface.The product can also serve as an ointment or medication carrier. 

3.6. Intended users 

The product shall be used by or under the supervision of a healthcare professional. 

3.7. Intended patient population 

Patients who meet the intended use of the product. 

3.8. Function principle 

It is used directly on patient to absorb blood and exudates in body. 

3.9. Qualification of the product as a device 

The product is qualified as a device under the MDR, according to the definition of MDR, 

Articles 2 (1),The device is defined as medical device as its intended use. 

3.10. Products classification 

Our products were classified according to the requirement of MDRCE tech file of Non-woven Sponges Device Brief Description 

File No.: Q/JH.CE2-1-1101 

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According to the requirements of MDR Annex VIII Rule 4: 

All of the non-invasive devices that come into contact with injured skin or mucous membrane are classified as class I 

if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, so the 

Non-woven sponges products belong to class I. 

3.11. Conformity assessment 

According to the requirements of MDR, our company has decided to choose the following way to make conformity a 

ssessment for the above applying CE mark products: Non-woven sponges conformity assessment according to 

Article 19, Annex II and Annex III.

Detailed Photos