Optos plc

United Kingdom (ex Northern Ireland) GB-MF-000019460 Last updated 23 Oct 2026

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Devices: 17
Registries: EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls: 0

Catalogue17

P200MA Ref A10022

Class IIa EUDAMED Active
Panoramic 200A Ref K042001

Class II FDA 510(k) Active
OptosAdvance 4.0 Software Ref K162039

Class II FDA 510(k) Active
PANORAMIC200 Opthalmoscope Ref K983999

Class II FDA 510(k) Active
Daytona Icg (P200TICG) Ref K134039

Class II FDA 510(k) Active
Optos Oct/Slo Microperimeter Ref K121043

Class II FDA 510(k) Active
Optos Limited Panoramic 200CAF Ref K100644

Class II FDA 510(k) Active
P200MAAF Ref K102492

Class II FDA 510(k) Active
Panoramic, Model 200MA Ref K060424

Class II FDA 510(k) Active
OptosAdvance Ref S90570

Class IIa EUDAMEDFDA UDI Active
Silverstone Ref A10750

Class IIa EUDAMEDFDA UDI Active
California Ref A10650

Class IIa EUDAMEDFDA UDI Active
P200, P200Dx Ref A1021

Class IIa EUDAMED Active
Arm rest Ref A10804

Class I EUDAMEDFDA UDI Active
Daytona Ref A10600

Class IIa EUDAMEDFDA UDI Active
MonacoPro Ref A10700

Class IIa EUDAMEDFDA UDI Active
P200C Ref A10021

Class IIa EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TÜV Rheinland LGA Products GmbH 0197 2 certificates

HZ 1552432-1 Reissued

Quality management system EU MDR

Issued
28 Aug 2026

Expires
27 Sep 2031

Valid from
28 Sep 2026
HZ 1552432-1 Expired

Quality management system EU MDR

Issued
24 Nov 2025

Expires
27 Sep 2026

Authorised representatives

Emergo Europe B.V. NL

Notified bodies

TÜV Rheinland LGA Products GmbH 0197

Information

Country: United Kingdom (ex Northern Ireland)
Address: Queensferry House, Carnegie Campus, Dunfermline, United Kingdom (ex Northern Ireland)
Website: optos.com
Email: [email protected]
PRRC contact: Judith Kennedy
EUDAMED SRN: GB-MF-000019460
FDA FEI number: 3003060634