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MicroSTAAR

by STAAR Surgical AG Switzerland EUDAMEDGUDID

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Product code MSSEMDN P0380

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08415421MSIU7 Basic UDI-DIDate12 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840311344802 UDI-DIDate15 Jun 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3830100CE01 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    15 Aug 2024
    Expires
    15 Jul 2027
    Reason
    Mnf ar change

Recalls

1 recall · FDA

    • Terminated Z-0957-04 FDA Unclassified (pre-2012) initiated 21 Apr 2004 via K980696, on the same 510(k)

    Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Manual intraocular lens injector, single-use
Device Name
MicroSTAAR Injection (MSI) System
Model / Ref / Catalog
FTP
Primary DI / UDI-DI
00840311344802
Basic UDI-DI
08415421MSIU7
510(k) Number
FDA Product Code
MSS
EMDN Code
P0380 Ocular prostheses - accessories
GMDN Term
Manual intraocular lens injector, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4300
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000039544
Authorised representative
STAAR Surgical AG ES-AR-000025479

Other devices from STAAR Surgical AG

See all devices from STAAR Surgical AG →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • EUDAMED 9eae3ddc-6997-4142-99b5-22d33b8a3848 61 fields · synced 22 Oct 2026
  • FDA UDI 7bb86344-9dde-4584-8a58-bd34abdaee13 36 fields · synced 30 May 2026