Pure Global

Geo CMFit Abutment - EUDAMED Registration 08800028713249

Access comprehensive regulatory information for Geo CMFit Abutment in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 08800028713249 and manufactured by GeoMedi Co., Ltd. in Republic of Korea.

This page provides complete registration details including 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 IIb
08800028713249
No
Geo CMFit Abutment
EU EUDAMED Registered Medical Device
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

DENTAL IMPLANTS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P01020101
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800028713249
Basic UDI
B-08800028713249
Version Date
October 21, 2022
Manufacturer Last Update
May 12, 2022
Active Status
No
Manufacturer
Manufacturer Name
GeoMedi Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
#702,703,704,709-1, Unit D 40, imi-ro, Indeokwon IT Valley, Uiwang-si,
Email
dhkim@geomedi.com
Authorized Representative
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory Information
Competent Authority
DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
Poland:None~None, Romania:2022-09-01~2022-09-05
Device Characteristics
Human Tissues
No
Animal Tissues
No