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FOOT ORTHOSES - EUDAMED Registration 00840269509377

Access comprehensive regulatory information for FOOT 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 00840269509377 and manufactured by La Pointique Int´l Ltd. in United States.

This page provides complete registration details including trade name (Digicare Elastic Caps), 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.

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EUDAMED Official Data
Class I
00840269509377
No
FOOT ORTHOSES
Trade Name: Digicare Elastic Caps
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Device Description (EMDN)

ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y061203
Trade Name
Digicare Elastic Caps
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840269509377
Basic UDI
08402695CL1068N
Version Date
October 18, 2024
Manufacturer Last Update
May 26, 2021
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
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, Finland:None~None, Germany:None~None, Greece:None~None, Netherlands:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No