Skip to content

BSN2820

by B&L Biotech 2 variants

Model BP-B1

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000191MINIMY Basic UDI-DI 08800019101710UDI-DIDate2 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019101710 UDI-DI Date15 Jun 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
BSN2820 EUDAMED
Needle GUDID
Generic Name
Endodontic obturation system
Device Name
Beta Mini
Model / Reference
BP-B1 EUDAMED
BSN2028 GUDID
Primary DI / UDI-DI
08800019101710
Basic UDI-DI
88000191MINIMY
FDA Product Code
EKR
EMDN Code
Q01010299 Root canal filling devices - other
GMDN Term
Endodontic obturation system
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BP-B1
none
GUDID
BSN2028
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from B&L Biotech

  • Sprds

    Class IIa

  • Sprdn

    Class IIa

  • Leetrac

    Class I

  • BSN2123

    Class IIa

  • BMN2425

    Class IIa

  • BSN2225

    Class IIa

See all devices from B&L Biotech →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No