EUDAMED registration 08800019100201YesSuperEndo-Alpha II
- Risk class
- Class IIa
- CND nomenclatures code
- Q01010299
- Trade name
- BP5506
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 08800019100201
- Basic UDI
- 88000191ALPHAFS
- Active status
- Yes
- Manufacturer name
- B&L Biotech
- Country
- Republic of Korea
- Country type
- NON_EU
- Address
- 95 Gwangdeokdong-ro, Danwon-gu Ansan-si
- bnl@bnlbio.com
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- 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
- Human tissues
- No
- Animal tissues
- No
ROOT CANAL FILLING DEVICES - OTHER
Access comprehensive regulatory information for SuperEndo-Alpha II 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 08800019100201 and manufactured by B&L Biotech in Republic of Korea.
This page provides complete registration details including trade name (BP5506), 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.