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SINUS SET - EUDAMED Registration D123102132S0

Access comprehensive regulatory information for SINUS SET 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 D123102132S0 and manufactured by Dental Expert in Pakistan.

This page provides complete registration details including trade name (DENTAL SINUS SET), manufacturer information, authorized representative details, competent authority (DE/CA38 - Regierungsprรคsidium 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
D123102132S0
No
SINUS SET
Trade Name: DENTAL SINUS SET
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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
DENTAL SINUS SET
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
D123102132S0
Basic UDI
++D123102132SHK
Version Date
August 03, 2024
Manufacturer Last Update
June 01, 2022
Active Status
No
Manufacturer
Manufacturer Name
Dental Expert
Country
Pakistan
Country Type
NON_EU
Address
237-A Street No.18, MAG TOWN, SIALKOT, PAKISTAN 51310 Sialkot
Email
azambhatti71@gmail.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 - Regierungsprรคsidium Karlsruhe
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No