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Slt

by Zumax Medical CO., LTD. China EUDAMEDGUDID

Ref 50BL2550

Product code HJHEMDN Q0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06945095548812 UDI-DIDate3 Jun 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number69450955binocularloupesYV Basic UDI-DIDate7 May 2026RegisteredStatusActive

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

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

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Slt EUDAMED
zumax GUDID
Generic Name
Surgical binoculars, reusable
Device Name
Binocular Loupes
Model / Ref / Catalog
50BL2550, SLT
Primary DI / UDI-DI
06945095548812, 06945095547044
Basic UDI-DI
69450955binocularloupesYV
FDA Product Code
HJH
EMDN Code
Q0299 Ophthalmic devices - other
GMDN Term
Surgical binoculars, reusable
Device Class
Class I
Regulation Number
886.5120
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
50BL2550
GUDID
SLT

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zumax Medical Co., LTD

See all devices from Zumax Medical Co., LTD →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable YesEUDAMEDNoEUDAMED
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • Sterile: No
  • Single Use: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED 4abde7ba-3fab-42c2-b349-90b9600d3ec7 61 fields · synced 22 Oct 2026
  • EUDAMED 06945095547044|69450955BINOCULARLOUPESYV 61 fields · synced 13 Jul 2026
  • FDA UDI 21c5ae41-a3b5-48bf-b14b-945908c5a197 33 fields · synced 22 Oct 2026
  • FDA UDI 4ffacd80-4d40-424f-8e8e-cd686ca5b257 33 fields · synced 22 Oct 2026