Pure Global
00713980022473

BIOSTEP LP

Alps South, LLC·Class I·EU EUDAMED·Trade name: BioStep LP, Size 25, Right, Rate ENo
Device classification
Risk class
Class I
CND nomenclatures code
Y062499
Trade name
BioStep LP, Size 25, Right, Rate E
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00713980022473
Basic UDI
0713980100040057N
Active status
No
Manufacturer
Manufacturer name
Alps South, LLC
Country
United States
Country type
NON_EU
Address
2895 42nd Avenue North St. Petersburg
Email
dbaldwin@easyliner.com
Authorized representative
Name
CEpartner4U
SRN
NL-AR-000000111
Country
Netherlands
Address
13 Esdoornlaan Maarn
Email
office@cepartner4u.com
Telephone
+31343442524
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Italy
Market available
Bulgaria:2022-03-29~None, Croatia:2022-03-29~None, Czechia:2022-03-29~None, Denmark:2022-03-29~None, Estonia:2022-03-29~None, Finland:2022-03-29~None, France:2022-03-29~None, Germany:2022-03-29~None, Greece:2022-03-29~None, Hungary:2022-03-29~None, Italy:2022-03-29~None, Latvia:2022-03-29~None, Lithuania:2022-03-29~None, Norway:2022-03-29~None, Poland:2022-03-29~None, Portugal:2022-03-29~None, Romania:2022-03-29~None, Slovakia:2022-03-29~None, Slovenia:2022-03-29~None, Spain:2022-03-29~None, Sweden:2022-03-29~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

LOWER EXTREMITY PROSTHESES - OTHER

About this record

Access comprehensive regulatory information for BIOSTEP LP 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 00713980022473 and manufactured by Alps South, LLC in United States.

This page provides complete registration details including trade name (BioStep LP, Size 25, Right, Rate E), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.