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Sprds

by B&L Biotech

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

Ref SPRDSModel CL-A1

Sprds is a medical device (EU MDR Class IIa; EMDN category root canal filling devices) made by B&L Biotech, registered in EUDAMED on 14 May 2026 (Basic UDI-DI B-08800019100256), 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/MDR NumberB-08800019100256 Basic UDI-DI 08800019100256UDI-DIDate14 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08800019100256 Basic UDI-DI 08800019100256UDI-DIDate14 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
SuperEndo-Alpha II
Model / reference
SPRDS, CL-A1
Primary DI / UDI-DI
08800019100256
Basic UDI-DI
B-08800019100256, 88000191ALPHAFS
EMDN code
Q01010299 Root canal filling devices - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
Standard device
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

  • Sprdn

    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)