Operation Room Gel Positioning Pad
- Risk class
- Class I
- CND nomenclatures code
- Z12011299
- Trade name
- CONTOURED CHEST ROLLS
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08809238796912
- Basic UDI
- 880923879LBT001LM
- Version date
- March 25, 2024
- Manufacturer last update
- May 18, 2022
- Active status
- No
- Manufacturer name
- Libertech Corporation
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 1352 Poseungjangan-ro 18584 Hwaseong-si
- operation@libertech.co.kr
- Name
- JaviTech e.K.
- SRN
- DE-AR-000005875
- Country
- Germany
- Address
- 16 Sachsenhausener Str. Schwalbach am Taunus
- info@javitech.de
- Telephone
- +49 176 7298 9240
- Competent authority
- DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Human tissues
- No
- Animal tissues
- No
PATIENT POSITIONING INSTRUMENTS – OTHER
Access comprehensive regulatory information for Operation Room Gel Positioning Pad in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 08809238796912 and manufactured by Libertech Corporation in Republic of Korea.
This page provides complete registration details including trade name (CONTOURED CHEST ROLLS), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.