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MDR CE and Air Warming Blanket

MDR CE and Air Warming Blanket

MDR CE and Air Warming Blanket

Product catalog summary
Product Specifications:
  • Customizable accessories for various countries.
  • Over 60 size options available.
  • Both disposable and reusable blankets offered.
  • Compatible with multiple brands including 3M Bair Hugger and Medtronic WarmTouch.
  • Features include cardboard gathering vent and rope for no hot air leakage, three-layer structure for improved insulation, and more pores for thermal circulation.
  • Vacuum packaging for reduced shipping costs.
Certification Details:
  • Certificate of Conformity Number: UNICO20250519XS03.
  • Test Report Number: TZSHZH2505196XS03.
  • Holder: Jiangsu Bairun Medical Technology Co., Ltd., China.
  • European Representative: Riomavix S.L., Spain.
  • CE marking compliance with Regulation (EU) 2017/745 on Medical Devices.
  • Standards: EN ISO13485:2016, EN ISO14971:2019, EN ISO 10993-1:2020, EN ISO 10993-5:2009/A11:2025, EN ISO 10993-10:2023.
  • Product: Air Warming Blanket, various models listed.
  • Conformity Assessment: AnnexⅡ+Ⅲ of Regulation (EU) 2017/745.
  • Classification: Class I, Non-sterile, No measuring function.
  • Issue Date: May 19, 2025; Expiry Date: May 18, 2030.
  • Certification by RENOWS CERTIFICATION TESTING CO., LTD, UK.
Additional Information:
  • Common sizes are usually in stock for prompt shipment.
  • Purchase of 1000 pieces (mixed sizes) includes a free Warm-pro controller with accessories.
  • Special production available for non-standard sizes.
  • Development of sizes for pets, offering reusable and scratch-resistant options.
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Catalog excerpts

MDR CE and Air Warming Blanket-1

♦Complete accessories, have ability to be customized for various countries. ♦ More than 60 kinds of sizes for choice. ♦ Both Disposable and Reusable blankets for choice. ♦ Match our controller Warm-pro well, and also can Compatible with many other brands of devices as 3M Bair Hugger, Medtronic WarmTouch, Sterisets, etc.

 Open the catalog to page 1
MDR CE and Air Warming Blanket-2

Both Cardboard Gathering Vent and Rope, Double guarantee, no leakage of hot air More pores to ensure thermal circulation Three layer structure to improve insulation performance Vacuum package, effectively compresses volume, saving shippin

 Open the catalog to page 2
MDR CE and Air Warming Blanket-3

Certificate Zertifikat Certificate Certificat Certyfikat g CERTIFICATE OF CONFORMITY Certificate Number:UNICO20250519XS03 Test Report no. TZSHZH2505196XS03 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....

 Open the catalog to page 3
MDR CE and Air Warming Blanket-4

Full body blanket Larger Full body blanket Upper limb blanket Larger Upper limb blanket With hole Full body blanket Upper body blanket Lower body blanket

 Open the catalog to page 4
MDR CE and Air Warming Blanket-6

♦As to above common sizes, we commonly have stock for prompt shipment. ♦ Buying common sizes 1000PCS ( Different sizes can be mixed to accounted to reach 1000pcs), then one controller Warm-pro with all necesary accessories can be free of charge. ♦ If the size you needed is not our common size, kindy pls contact us for special producing. ♦According the developing pet economy, some sizes are also developed for various pets. kindly pls feel free to consult and customize, reusable, scratch resistant and scratch resistant.

 Open the catalog to page 6

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.