Sara Stedy - EUDAMED Registration 05055982787499
Access comprehensive regulatory information for Sara Stedy 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 05055982787499 and manufactured by ArjoHuntleigh AB in Sweden.
This page provides complete registration details including trade name (Walker), manufacturer information, competent authority (Swedish Medical Products Agency), 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.
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EUDAMED Official Data
Class I
05055982787499
No
Sara Stedy
Trade Name: Walker
Device Description (EMDN)
STANDING SUPPORT GAIT TRAINERS
Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y050201
Trade Name
Walker
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05055982787499
Basic UDI
5060693520235W4
Version Date
March 07, 2025
Manufacturer Last Update
February 03, 2025
Active Status
No
Manufacturer
Manufacturer Name
ArjoHuntleigh ABCountry
Sweden
Country Type
EU_MEMBER_STATE
Address
Hans Michelsensgatan 10 Malmö
Email
info@arjo.com
Regulatory Information
Competent Authority
Swedish Medical Products Agency
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:None~None, Belgium:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Finland:None~None, France:None~None, Germany:None~None, Iceland:None~None, Italy:None~None, Liechtenstein:None~None, Luxembourg:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No