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Bausch + Lomb BL5115-2

by Bausch & Lomb Incorporated

Ref BL5115-2

Bausch + Lomb BL5115-2 is an ophthalmic surgical procedure kit (EU MDR Class IIb; FDA Class II) made by Bausch & Lomb Incorporated, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 0310119B1033ZD) and listed in FDA GUDID since 2 Aug 2018 (UDI-DI 10757770058850), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0310119B1033ZD Basic UDI-DI 10757770058850UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10757770058850 UDI-DI Date2 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0310119B1033ZD registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 10757770058850 listed 2 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10757770058850
  2. Registered EUDAMED 0310119B1033ZD

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Stellaris Elite EUDAMED
Bausch + Lomb GUDID
Generic name
Ophthalmic surgical procedure kit, non-medicated, single-use
Device name
Stellaris Elite Procedure Packs
Model / Ref / Catalog
BL5115-2
Primary DI / UDI-DI
10757770058850
Basic UDI-DI
0310119B1033ZD
FDA product code
HQE, HQC
EMDN code
Q020680 Phacoemulsification devices - accessories
GMDN term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4150, 886.4670
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Similar devices in this category

Other devices filed under PHACOEMULSIFICATION DEVICES.

Other devices from Bausch & Lomb Incorporated

See all devices from Bausch & Lomb Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)