Sanyo Chemical Industries, Ltd.
Announce
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Sanyo Chemical Industries, Ltd. announced that sales of “AQUABRID” certified under Medical Device Regulation (MDR) was begun from February 2025.
Product Information
AQUABRID™ Surgical Sealant
AQUABRID™ is a new synthetic hemostatic material to which our core, urethane technology, is applied.
-Instead of relying on the blood coagulation ability of the patient, it reacts using the water on the surface of blood vessels and forms a cured film with tissue adhesiveness.
-The cured film has the flexibility to follow movements such as the pulsation of blood vessels.
-It is a synthetic hemostatic material that does not use bio-based materials.
Item Specifications
| Item specifications | ・ Surgical sealant (content 2g) ・ Sheet (content 2 sheets) ・ Spatula (content 1 spatula) |
|---|
Manufacturer/
Authorized representative/Importer
SANYO CHEMICAL INDUSTRIES, LTD.
11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto 605-0995, Japan
https://www.sanyo-chemical.co.jp/eng/medical_device/
TERUMO EUROPE N.V.
Interleuvenlaan 40, 3001 Leuven, Belgium
https://www.terumo-europe.com
VASCUTEK Deutschland GmbH t/a TERUMO Aortic
Luruper Chaussee 125, Haus 8 - Mitte D-22761 Hamburg, Germany
https://www.terumoaortic.com
VASCUTEK Deutschland GmbH t/a TERUMO Aortic
Zweigniederlassung Schweiz
Bodenäckerstrasse 3, CH-8957 Spreitenbach, Switzerland
https://www.terumoaortic.com
IFU
You can download electronic copies of IFU.
| Language | IFU | |
|---|---|---|
| Issue date | PDF file | |
| All | 2024-10 | AQUABRID R2.1 all |
| English | 2024-10 | AQUABRID R2.1 en |
| French | 2024-10 | AQUABRID R2.1 fr |
| German | 2024-10 | AQUABRID R2.1 de |
| Spanish | 2024-10 | AQUABRID R2.1 es |
| Portuguese | 2024-10 | AQUABRID R2.1 pt |
| Italian | 2024-10 | AQUABRID R2.1 it |
| Dutch | 2024-10 | AQUABRID R2.1 nl |
| Swedish | 2024-10 | AQUABRID R2.1 sv |
| Danish | 2024-10 | AQUABRID R2.1 da |
| Norwegian | 2024-10 | AQUABRID R2.1 no |
| Finnish | 2024-10 | AQUABRID R2.1 fi |
| Icelandic | 2024-10 | AQUABRID R2.1 is |
| Greek | 2024-10 | AQUABRID R2.1 el |
| Polish | 2024-10 | AQUABRID R2.1 pl |
| Hungarian | 2024-10 | AQUABRID R2.1 hu |
| Czech | 2024-10 | AQUABRID R2.1 cs |
| Slovak | 2024-10 | AQUABRID R2.1 sk |
| Bulgarian | 2024-10 | AQUABRID R2.1 bg |
| Romanian | 2024-10 | AQUABRID R2.1 ro |
| Turkish | 2024-10 | AQUABRID R2.1 tr |
| Estonian | 2024-10 | AQUABRID R2.1 et |
| Latvian | 2024-10 | AQUABRID R2.1 lv |
| Lithuanian | 2024-10 | AQUABRID R2.1 lt |
| Slovenian | 2024-10 | AQUABRID R2.1 sl |
| Serbian | 2024-10 | AQUABRID R2.1 sr |
| Croatian | 2024-10 | AQUABRID R2.1 hr |
| Arabic | 2024-10 | AQUABRID R2.1 ar |
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About Symbol
See the description of each Symbol.
Archives
| Language | IFU (Old Version) | |
|---|---|---|
| Issue date | PDF file | |
| ALL | 201906 | IFU_full(ver.1) (2.56 MB) |
SSCP
You can download this Summary of Safety and Clinical Performance (SSCP) from EUDAMED.
https://ec.europa.eu/tools/EUDAMED (BASIC UDI-DI: 45805141800000000000001GH)
Corporate Information
Sanyo chemical industries, Ltd. is a manufacturer of performance chemicals, established in 1949 in Kyoto. Performance chemicals featuring by functional characteristics meet various needs such as being more comfortable and environment friendlier. Sanyo Chemical started as a manufacturer of soap and textile agents, and has since diversified ourproduct line to satisfy the needs of the market. Sanyo Chemical company operates in six business segments: toiletries & health, petroleum & automotive, plastic, textiles, info/electronic & construction/others. Their solutions are essential to our daily lives from automotive to daily electronics, to cosmetics and medical products. Now Sanyo Chemical distributes over 3,000 different types of products and maintains an international presence. Sanyo Chemical endeavors tocreate better life and society through performance chemicals in various fields.
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