Pure Global

Immobilisation bandages - EUDAMED Registration 00840270602951

Access comprehensive regulatory information for Immobilisation bandages 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 00840270602951 and manufactured by OPPO Medical Inc. in United States.

This page provides complete registration details including trade name (Posture Aid/clavicle Brace), manufacturer information, authorized representative details, competent authority (DE/CA70 - Landesamt fรผr 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
00840270602951
No
Immobilisation bandages
Trade Name: Posture Aid/clavicle Brace
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M030501
Trade Name
Posture Aid/clavicle Brace
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840270602951
Basic UDI
08402706CL1014K
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-StraรŸe St. Ingbert
Email
ear@mt-procons.com
Telephone
+49 6894 581020
Regulatory Information
Competent Authority
DE/CA70 - Landesamt fรผr Umwelt- und Arbeitsschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Greece:None~None, Italy:None~None, Latvia:None~None, Malta:None~None, Poland:None~None, Portugal:None~None, Slovakia:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No