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mse-11 - EUDAMED Registration 08800099999849

Access comprehensive regulatory information for mse-11 in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 08800099999849 and manufactured by BioMaterials Korea, Inc. in Republic of Korea.

This page provides complete registration details including trade name (Maxillary Skeletal Expander), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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 IIa
08800099999849
No
mse-11
Trade Name: Maxillary Skeletal Expander
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Device Description (EMDN)

ORTHODONTIC DENTAL PROSTHESES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q01020604
Trade Name
Maxillary Skeletal Expander
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800099999849
Basic UDI
B-08800099999849
Version Date
February 12, 2025
Manufacturer Last Update
October 08, 2024
Active Status
No
Manufacturer
Manufacturer Name
BioMaterials Korea, Inc.
Country
Republic of Korea
Country Type
NON_EU
Address
Hanam-si, Gyeonggi-do
Email
info@biomk.com
Authorized Representative
SRN
DE-AR-000005685
Country
Germany
Address
77 Mergenthalerallee Eschborn
Email
ktreurope@ktreurope.de
Telephone
+49 6196 887 170
Regulatory Information
Competent Authority
DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Spain
Market Available
Spain:2017-01-27~2024-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No