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EUDAMED registration 08809238798688No

Operation Room Gel Positioning Pad

Libertech CorporationClass IEU EUDAMEDTrade name: PRONE HEAD REST WITH MIRROR (FRAME)
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12011299
Trade name
PRONE HEAD REST WITH MIRROR (FRAME)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08809238798688
Basic UDI
880923879LBT001LM
Active status
No
Manufacturer
Manufacturer name
Libertech Corporation
Country
Republic of Korea
Country type
NON_EU
Address
1352 Poseungjangan-ro 18584 Hwaseong-si
Email
operation@libertech.co.kr
Authorized representative
Name
JaviTech e.K.
SRN
DE-AR-000005875
Country
Germany
Address
16 Sachsenhausener Str. Schwalbach am Taunus
Email
info@javitech.de
Telephone
+49 176 7298 9240
Regulatory information
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
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PATIENT POSITIONING INSTRUMENTS – OTHER

About this record

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 08809238798688 and manufactured by Libertech Corporation in Republic of Korea.

This page provides complete registration details including trade name (PRONE HEAD REST WITH MIRROR (FRAME)), 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.