Pure Global

DENTALEXPANDER SET - EUDAMED Registration D12317230

Access comprehensive regulatory information for DENTALEXPANDER 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 D12317230 and manufactured by Dental Expert in Pakistan.

This page provides complete registration details including trade name (DENTAL EXPANDER SET), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
D12317230
No
DENTALEXPANDER SET
Trade Name: DENTAL EXPANDER SET
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

DENTAL MATERIAL PROCESSING MILLS, REUSABLE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
L15900601
Trade Name
DENTAL EXPANDER SET
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
D12317230
Basic UDI
++D1231723VR
Version Date
April 15, 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 - Regierungspräsidium Karlsruhe
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No