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ORTHOSIS, LUMBOSACRAL SPINE - EUDAMED Registration 04717237005826

Access comprehensive regulatory information for ORTHOSIS, LUMBOSACRAL SPINE 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 04717237005826 and manufactured by I-Ming Sanitary Materials Co.,Ltd in Taiwan.

This page provides complete registration details including trade name (Comfort-Pull Mesh Back Brace w/ Adj. Side Panel ), 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.

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EUDAMED Official Data
Class I
04717237005826
No
ORTHOSIS, LUMBOSACRAL SPINE
Trade Name: Comfort-Pull Mesh Back Brace w/ Adj. Side Panel
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Device Description (EMDN)

LUMBOSACRAL SPINE ORTHOSES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Y060308
Trade Name
Comfort-Pull Mesh Back Brace w/ Adj. Side Panel
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04717237005826
Basic UDI
4717237LSOG9
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
NO.68ใ€88,Sec.2, Zhongke Erlin Blvd. Changhua
Email
IMING@SUPPORTS.COM.TW
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
Spain
Device Characteristics
Human Tissues
No
Animal Tissues
No