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Beta Mini - EUDAMED Registration 08800019101697

Access comprehensive regulatory information for Beta Mini 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 08800019101697 and manufactured by B&L Biotech in Republic of Korea.

This page provides complete registration details including trade name (BSN2220), 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 IIa
08800019101697
Yes
Beta Mini
Trade Name: BSN2220
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Device Description (EMDN)

ROOT CANAL FILLING DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q01010299
Trade Name
BSN2220
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800019101697
Basic UDI
88000191MINIMY
Active Status
Yes
Manufacturer
Manufacturer Name
B&L Biotech
Country
Republic of Korea
Country Type
NON_EU
Address
95 Gwangdeokdong-ro, Danwon-gu Ansan-si
Email
bnl@bnlbio.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Denmark
Market Available
Denmark:None~None, Finland:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Spain:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No