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Insert

by FertiPro

Ref SPF_VIALModel SPF_BOX

Insert (SPF_VIAL) is a Class I device made by FertiPro, registered in EUDAMED on 11 Jan 2023 (Basic UDI-DI 5411967SPFBOX15C), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5411967SPFBOX15C Basic UDI-DI 05411967007820UDI-DIDate11 Jan 2023RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SpermFreeze Box
Model / reference
SPF_BOX, SPF_VIAL
Primary DI / UDI-DI
05411967007820
Basic UDI-DI
5411967SPFBOX15C
EMDN code
U08020599 Substrates for storing/handling biological material for assisted reproduction - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000313

Similar devices in this category

Other devices filed under SUBSTRATES FOR STORING/HANDLING BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION.

Other devices from FertiPro

See all devices from FertiPro →

Properties

Other properties (14, all answered No)