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Knee orthoses - EUDAMED Registration 00840270601848

Access comprehensive regulatory information for Knee 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 00840270601848 and manufactured by OPPO Medical Inc. in United States.

This page provides complete registration details including trade name ( OppO genu X), 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
00840270601848
No
Knee orthoses
Trade Name: OppO genu X
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Device Description (EMDN)

KNEE ORTHOSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y061209
Trade Name
OppO genu X
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840270601848
Basic UDI
08402706CL1134S
Active Status
No
Manufacturer
Manufacturer Name
OPPO Medical Inc.
Country
United States
Country Type
NON_EU
Address
Ste. 220080 Seattle City Center, 1420 Fifth Ave. Seattle
Email
brittanywang@oppomedical.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
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No