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LETIBALM Intranasal Protect

by LETI Pharma, S.L.U. 2 variants

Ref 31204002, 312960043Model LETIBALM Intranasal protect 15 ml and LETIBALM Intranasal protect 4 ml

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8431166INTRANASALC9 Basic UDI-DI Date21 Sep 2023RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
LETIBALM Intranasal protect 15 ml and LETIBALM Intranasal protect 4 ml, 31204002, 312960043
Primary DI / UDI-DI
08431166120387, 08431166121520
Basic UDI-DI
8431166INTRANASALC9
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
EU market of registration
Spain
Italy

Manufacturer details

EUDAMED SRN
ES-MF-000011559

Other devices from LETI Pharma, S.L.U.

Properties

Other properties (13)

  • 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