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Sprdn

by B&L Biotech

Part of a family of 14 devices: see the family page

Ref SPRDNModel CL-A1

Sprdn is a medical device (EU MDD Class IIa; EMDN category root canal filling devices) made by B&L Biotech, registered in EUDAMED on 2 Oct 2024 (Basic UDI-DI 88000191ALPHAFS), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number88000191ALPHAFS Basic UDI-DI 08800019100249UDI-DIDate2 Oct 2024RegisteredStatusActive
European UnionCE/MDR Number88000191ALPHAFS Basic UDI-DI 08800019100249UDI-DIDate2 Oct 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device name
SuperEndo-Alpha II
Model / reference
CL-A1, SPRDN
Primary DI / UDI-DI
08800019100249
Basic UDI-DI
88000191ALPHAFS, B-08800019100249
EMDN code
Q01010299 Root canal filling devices - other
Device class
Class IIa
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Denmark

Manufacturer details

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

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DEVICES - OTHER.

Other devices from B&L Biotech

  • Sprds

    Class IIa

  • Leetrac

    Class I

  • BSN2123

    Class IIa

  • BMN2425

    Class IIa

See all devices from B&L Biotech →

Properties

  • Sterilise before use
Other properties (13, all answered No)