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Labomed

by Labotech Microscopes India Pvt. Ltd. EUDAMEDGUDID

Active European Union and United States

Ref 8127300 / 8126300-796Model 8127303,8126303.8127300,8126300,8127201,8126201,8127200,8126200,8127401,8126401,8127400,8126400,8127701,8126701,8127700,8126700

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8908006463SLITLAMP812RN Basic UDI-DIDate19 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08908006463589 UDI-DIDate17 Jun 2023ListedStatusListed

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  • Withdrawn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

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Labomed EUDAMED
LABOMED eVO450 5-Step Slit lamp -Halogen (HL) GUDID
Generic Name
Ophthalmic examination slit lamp
Device Name
Labomed Slit Lamp
Model / Reference
8127303 EUDAMED
8126303.8127300 EUDAMED
8126300 EUDAMED
8127201 EUDAMED
8126201 EUDAMED
8127200 EUDAMED
8126200 EUDAMED
8127401 EUDAMED
8126401 EUDAMED
8127400 EUDAMED
8126400 EUDAMED
8127701 EUDAMED
8126701 EUDAMED
8127700 EUDAMED
8126700 EUDAMED
8127300 / 8126300-796 EUDAMED
8127300 GUDID
Primary DI / UDI-DI
08908006463589
Basic UDI-DI
8908006463SLITLAMP812RN
Direct Marketing DI
08908006463589
FDA Product Code
PUE
EMDN Code
Z12120108 Slit lamps
GMDN Term
Ophthalmic examination slit lamp
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
886.1850
Market of Registration
Netherlands
Commercial Distribution
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IN-MF-000033373
Authorised representative
Labomed Europe b.v. NL-AR-000022889

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Properties

Show properties
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Lot / Batch Number: No
  • Expiration Date: No