Pure Global

Becker GEO - EUDAMED Registration 00194545171346

Access comprehensive regulatory information for Becker GEO 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 00194545171346 and manufactured by Becker Orthopedic Appliance Company in United States.

This page provides complete registration details including trade name (Triple Action Flat Footplate Stirrup Large 1/4" Offset), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
00194545171346
No
Becker GEO
Trade Name: Triple Action Flat Footplate Stirrup Large 1/4" Offset
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

PASSIVE ANKLE-FOOT ORTHOSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y06120601
Trade Name
Triple Action Flat Footplate Stirrup Large 1/4" Offset
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00194545171346
Basic UDI
194545GEOWM
Version Date
January 28, 2025
Manufacturer Last Update
May 07, 2021
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
635 Executive Drive TROY
Email
eguice@beckerorthopedic.net
Authorized Representative
SRN
IE-AR-000000592
Country
Ireland
Address
Knockmorris Co. Tipperary
Email
prrc@acornregulatory.com
Telephone
+ 353 52 6176706
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No