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Remidio INSTAREF R20

by Remidio Innovative Solutions Private Limited

Ref 1000010021Model Instaref R20

Remidio INSTAREF R20 (1000010021) is a device classified as Class IIa in the EU and Class I in the US made by Remidio Innovative Solutions Private Limited, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 890609652INSTAREFR20S3) and listed in FDA GUDID since 6 Jul 2023 (UDI-DI 08906096520076), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number890609652INSTAREFR20S3 Basic UDI-DI 08906096520076UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08906096520076 UDI-DI Date6 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 890609652INSTAREFR20S3 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 08906096520076 listed 6 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08906096520076
  2. Registered EUDAMED 890609652INSTAREFR20S3

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  • Withdrawn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
Remidio Instaref EUDAMED
Remidio GUDID
Generic name
Automated ophthalmic refractometer
Model / Ref / Catalog
INSTAREF R20, 1000010021
Primary DI / UDI-DI
08906096520076
Basic UDI-DI
890609652INSTAREFR20S3
FDA product code
HKO
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Automated ophthalmic refractometer
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.1760
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Automated ophthalmic refractometer

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)