Pure Global AI
EUDAMED registration 00885914040683No

Splinting

Performance Health Supply, LLCClass IEU EUDAMEDTrade name: ROLYAN THERMOPLASTIC SHEET
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
M03050202
Trade name
ROLYAN THERMOPLASTIC SHEET
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00885914040683
Basic UDI
08859140000000000000003KQ
Version date
February 21, 2025
Manufacturer last update
September 10, 2021
Active status
No
Manufacturer
Manufacturer name
Performance Health Supply, LLC
Country
United States
Country type
NON_EU
Address
W68 N158 Evergreen Blvd Cedarburg
Email
Paul.Hanneman@performancehealth.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
France
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, Ireland:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SYNTHETIC CAST BANDAGES AND SPLINTS

About this record

Access comprehensive regulatory information for Splinting 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 00885914040683 and manufactured by Performance Health Supply, LLC in United States.

This page provides complete registration details including trade name (ROLYAN THERMOPLASTIC SHEET), 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.