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Sil-Select Plus - 16 preparations

by FertiPro

Ref SIP016

Sil-Select Plus - 16 preparations (SIP016) is a Class III device made by FertiPro, registered in EUDAMED on 16 Sep 2025 (Basic UDI-DI 5411967DENSGPROPACK1V6), active as of 25 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5411967DENSGPROPACK1V6 Basic UDI-DI 05411967002580UDI-DIDate16 Sep 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Sil-Select Plus
Model / reference
SIP016
Primary DI / UDI-DI
05411967002580
Basic UDI-DI
5411967DENSGPROPACK1V6
EMDN code
U08020502 Materials/solutions for preparation/handling for assisted reproduction
Device class
Class III
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Density Gradient media are used as sperm preparation method for intrauterine insemination (IUI), in vitro fertilization (IVF), intra-cytoplasmic sperm injection (ICSI), and related assisted reproductive technologies (ART).

Manufacturer details

EUDAMED SRN
BE-PR-000000330

Similar devices in this category

Other devices filed under MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION.

Other devices from FertiPro

See all devices from FertiPro →

Properties

  • Supplied sterile
Other properties (1, all answered No)