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MicroStaar SFC-45

by Staar Surgical Co.

Part of a family of 6 devices: see the family page

Ref SFC-45

MicroStaar SFC-45 is a device classified as Class IIa in the EU and Class I in the US made by Staar Surgical Co., registered in EUDAMED on 12 Mar 2025 (Basic UDI-DI 08415421MSIU7) with CE/MDR certificate 3830100CE01 valid until 15 Jul 2027, cleared under FDA 510(k) K152357 on 30 Oct 2015 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 00840311344796), active as of 22 Oct 2026.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

15 Jul 2027

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K152357

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08415421MSIU7 Basic UDI-DI 00840311344796UDI-DIDate12 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840311344796 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK152357 Date30 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08415421MSIU7 registered 12 Mar 2025 Active· +1 more in the status table
  • FDA 510(k) K152357 decided 30 Oct 2015 Active
  • FDA GUDID UDI-DI 00840311344796 listed 15 Jun 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3830100CE01 Expiring Amended Expires in 244 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Aug 2024
    Expires
    15 Jul 2027
    Reason
    Mnf ar change

Timeline

5 dated events

  1. Cleared FDA 510(k) K152357
  2. Listed FDA GUDID 00840311344796
  3. Certificate issued EUDAMED 3830100CE01
  4. Registered EUDAMED 08415421MSIU7
  5. Certificate expires EUDAMED 3830100CE01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MicroStaar
Generic name
Intraocular lens-insertion cartridge
Device name
MicroSTAAR Injection (MSI) System
Model / Ref / Catalog
SFC-45
Primary DI / UDI-DI
00840311344796
Basic UDI-DI
08415421MSIU7
510(k) Number
FDA product code
MSS, KYB
EMDN code
P0380 Ocular prostheses - accessories
GMDN term
Intraocular lens-insertion cartridge
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4300
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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Properties

  • Supplied sterile
  • Single use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)