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IPR Files - EUDAMED Registration 08908018231015

Access comprehensive regulatory information for IPR Files 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 08908018231015 and manufactured by Sawbros Industries Pvt. Ltd. in India.

This page provides complete registration details including trade name (Prime ortho), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
08908018231015
No
IPR Files
Trade Name: Prime ortho
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Device Description (EMDN)

DENTAL INSTRUMENTS, SINGLE-USE - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010599
Trade Name
Prime ortho
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08908018231015
Basic UDI
89080182313006D
Version Date
May 25, 2023
Manufacturer Last Update
November 17, 2021
Active Status
No
Manufacturer
Country
India
Country Type
NON_EU
Address
A68, Sector 2, Noida Uttar Pradesh
Email
sawbrosindia@gmail.com
Authorized Representative
SRN
NL-AR-000000594
Country
Netherlands
Address
Keizersgracht 482 Amsterdam
Email
nk@meddevices.net
Telephone
+31202254558
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No