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EUDAMED registration 00810080700710No

Surestep Sneakers - Black/Gray Suede

Surestep, LLCClass IEU EUDAMEDTrade name: Surestep
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Y063303
Trade name
Surestep
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00810080700710
Basic UDI
0081008070SSSNBGV9
Version date
September 17, 2022
Manufacturer last update
April 15, 2021
Active status
No
Manufacturer
Manufacturer name
Surestep, LLC
Country
United States
Country type
NON_EU
Address
17530 DUGDALE DR SOUTH BEND, INDIANA
Email
suzik@surestep.net
Authorized representative
Name
MedEnvoy Global BV
SRN
NL-AR-000024028
Country
Netherlands
Address
33 Prinses Margrietplantsoen The Hague
Email
EU-AR@medenvoyglobal.com
Telephone
+31 70 326 21 48
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

READY-MADE ORTHOTIC SHOES

About this record

Access comprehensive regulatory information for Surestep Sneakers - Black/Gray Suede 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 00810080700710 and manufactured by Surestep, LLC in United States.

This page provides complete registration details including trade name (Surestep), 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.