Pure Global

Operation Room Gel Positioning Pad - EUDAMED Registration 08809238798732

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 08809238798732 and manufactured by Libertech Corporation in Republic of Korea.

This page provides complete registration details including trade name (LARGE PRONE POSITIONER), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
08809238798732
No
Operation Room Gel Positioning Pad
Trade Name: LARGE PRONE POSITIONER
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

PATIENT POSITIONING INSTRUMENTS โ€“ OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12011299
Trade Name
LARGE PRONE POSITIONER
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08809238798732
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
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 - Regierungsprรคsidium 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