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MDR CE and Reusable Warming Blanket

MDR CE and Reusable Warming Blanket
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MDR CE and Reusable Warming Blanket

Product catalog summary
Certificate Overview
This Certificate of Conformity, issued to Jiangsu Bairun Medical Technology Co., Ltd., confirms compliance with the European Regulation (EU) 2017/745 on Medical Devices (MDR) for their Reusable Warming Blanket. The certificate is valid from May 19, 2025, to May 18, 2030, and is only valid if published on the Renows Certification Testing Co., Ltd website.
Product Specifications
  • Product: Reusable Warming Blanket
  • Models: M1 to M28, B1 to B9
  • Classification: Class I, Non-sterile, No measuring function
  • Conformity Assessment: AnnexⅡ+Ⅲ of Regulation (EU) 2017/745
Standards and Compliance
  • EN ISO13485:2016
  • EN ISO14971:2019
  • EN ISO 10993-1:2020
  • EN ISO 10993-5:2009/A11:2025
  • EN ISO 10993-10:2023
Key Features
  • Customizable accessories for various countries
  • Available in 37 sizes: 28 mattress types and 9 blanket types
  • Made from carbon fiber cloth for uniform heating
  • Far infrared heating with no leakage hazards
  • X-ray transmittable, no electromagnetic interference
  • Waterproof class ≥ IPX8 with multiple layers for protection
  • One-way breathable material to reduce bedsore risk
  • Operates on DC safe voltage 24V, continuous 24-hour operation
  • Reusable with a service life of 5-8 years
  • Free controller with purchase of mattress or blanket
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Catalog excerpts

MDR CE and Reusable Warming Blanket-2

The only manufacturer in China masters the high - density carbon fiber surface overall heating core technology Contact layer has the characteristics of high strength, softness, abrasion resistance and chemical resistance Comfort layer: temperature perception is more comfortable and not dry Insulation layer: double layer insulation with efficient protection Heating layer: flexible carbon fiber material with patent technology, and it is uniform heating, safe and reliable Insulation layer: insulation and energy saving Cushion layer: makes the patient relaxed and comfortable, and can prevent bedsore...

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MDR CE and Reusable Warming Blanket-3

Certificate Zertifikat Certificate Certificat Certyfikat g CERTIFICATE OF CONFORMITY Certificate Number:UNICO20250519XS01 Test Report no. TZSHZH2505196XS01 Based on our assessment we confirm that the product is in accordance with the technical requirements of the above standards and hence fulfils the technical requirements of the Regulation (EU) 2017/745 on Medical Devices (MDR) The manufacturer shall affix the CE marking to each product that is in conformity with those described in this Certificate, after completion of the EC Declaration of Conformity and in accordance with the above directive....

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MDR CE and Reusable Warming Blanket-5

Chose the different specifications of heating pad and lay it on the operating bed according to the operating position. It is used for the lower part of the patient's body and has the function of waterproof and preventing liquid, providing continuous temperature protection for the low er part of the patient. DC24V voltage heating is adopted to safeguard the safety of patients and medical staff Adopt flexible carbon liber materials with patented technology and it is heated evenly with high strength and long service life Seven-layer structure is more comfortable, safer and more scientific Built-in...

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MDR CE and Reusable Warming Blanket-7

Heating blanket can be used for preoperative, intraoperative and postoperative period, and can provide the temperature protection for upper part of patients. It is mainly used for the non-operative parts of patients during surgery. Combined with the three-dimensional insulation of the heating pad under the patients, the temperature protection is more scientific and reasonable. DC24V voltage heating is adopted to safeguard the safety of patients and medical staff Adopt flexible carbon fiber materials with patented technology and it is heated evenly with high strength and long service life Built-in...

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MDR CE and Reusable Warming Blanket-8

♦Complete accessories, have ability to be customized for various countries. ♦ More as 37 kinds of sizes for choice. Mattress has 28types, Blanket has 9 types, Fully meet the multiple needs ♦ Material is made of carbon fiber cloth with uniform heating throughoutthe surface and no cold hot spot, non-carbon fiber fabric, non-carbon fiber wire or carbon fiber hair wire. ♦ Carbon fiber heating, the principle is far infrared heating, heating uniform, no leakage hazards. X-ray transmittable, no electromagnetic interference to other equipment in operating room, no waste gas, no airflow, no noise, no...

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MDR CE and Reusable Warming Blanket-9

During the heating process, there is no swelling phenomenon and no exhaust valve. The probability of infection is reduced. ♦Adopt DC safe voltage 24V, no risk of electric shock, Work continuously for 24h without interruption. ♦ Doesn't contain consumables, can be reused, the service life of 5-8 years. ♦ Buy different size of mattress or blanket, the corresponding controller can be free of charge, more the quantity, higher the grade of the controller.

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