Pure Global
00840269522154

SPINE ORTHOSES

La Pointique Int´l Ltd.·Class I·EU EUDAMED·Trade name: Sacro Lumbar SupportNo
Device classification
Risk class
Class I
CND nomenclatures code
Y060399
Trade name
Sacro Lumbar Support
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00840269522154
Basic UDI
08402695CL1048J
Active status
No
Manufacturer
Manufacturer name
La Pointique Int´l Ltd.
Country
United States
Country type
NON_EU
Address
701 Fifth Ave, Suite 4200 Seattle
Email
kellyho@lp-support.com
Authorized representative
Name
Medical Technology Promedt Consulting GmbH
SRN
DE-AR-000000085
Country
Germany
Address
7 Ernst-Heckel-Straße St. Ingbert
Email
ear@mt-procons.com
Telephone
+49 6894 581020
Regulatory information
Competent authority
DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
Market available
Croatia:None~None, Czechia:None~None, Finland:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Netherlands:None~None, Poland:None~None, Slovakia:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SPINE ORTHOSES - OTHER

About this record

Access comprehensive regulatory information for SPINE ORTHOSES 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 00840269522154 and manufactured by La Pointique Int´l Ltd. in United States.

This page provides complete registration details including trade name (Sacro Lumbar Support), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz), 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.