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Silverstone

by Optos plc United Kingdom EUDAMED510(k)GUDID

Ref A10750Model P200TxE510(k) K190732

Product code OBOEMDN Z119082,Z12120114

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5057056107508P Basic UDI-DIDate8 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05057056107509 UDI-DIDate29 Oct 2019ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190732 Date31 Jul 2019ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

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

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
Silverstone EUDAMED
OCT Ophthalmoscope GUDID
Generic Name
Scanning-laser ophthalmoscope/retinal optical coherence tomography system
Device Name
OCT Ophthalmoscope - P200TxE
Model / Ref / Catalog
P200TxE, A10750
Primary DI / UDI-DI
05057056107509
Basic UDI-DI
5057056107508P
Direct Marketing DI
05057056107509
510(k) Number
FDA Product Code
MYC, OBO
EMDN Code
Z119082,Z12120114
GMDN Term
Scanning-laser ophthalmoscope/retinal optical coherence tomography system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.1570
Market of Registration
Northern Ireland
Commercial Distribution
In Commercial Distribution
Size
Depth — 570 Millimeter
Width — 540 Millimeter
Height — 683 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000019460
FDA applicant
Optos Plc.
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Optos plc

See all devices from Optos plc →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED ba06e5d9-cf99-4a76-af41-98f6674f33b8 85 fields · synced 22 Oct 2026
  • FDA UDI e22328b6-592c-42a3-98c4-5c5b8c40ed35 37 fields · synced 30 May 2026
  • FDA 510(k) K190732 1 fields · synced 18 May 2026