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1150588 - EUDAMED Registration G15511505880

Access comprehensive regulatory information for 1150588 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 G15511505880 and manufactured by Nadir & CO in Pakistan.

This page provides complete registration details including trade name (Bracket aligner with composite spatula 17cm), manufacturer information, authorized representative details, competent authority (DE/CA38 - Regierungspräsidium Karlsruhe), 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
G15511505880
No
1150588
Trade Name: Bracket aligner with composite spatula 17cm
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Device Description (EMDN)

DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L159003
Trade Name
Bracket aligner with composite spatula 17cm
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
G15511505880
Basic UDI
++G1551150588QA
Version Date
September 03, 2024
Manufacturer Last Update
August 01, 2022
Active Status
No
Manufacturer
Manufacturer Name
Nadir & CO
Country
Pakistan
Country Type
NON_EU
Address
Ugoki Road, Opp: Small Industrial Estate Shahab Pura 51310 Sialkot
Email
info@nadirco.com
Authorized Representative
SRN
DE-AR-000008078
Country
Germany
Address
6 Hans Bunte Strasse Heidelberg
Email
info@antex-medi-solution.de
Telephone
+4915678612574
Regulatory Information
Competent Authority
DE/CA38 - Regierungspräsidium Karlsruhe
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No