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Remidio 001

by Remidio Innovative Solutions Private Limited

Ref 1000010008Model FOP NM-10

Remidio 001 is a device classified as Class IIa in the EU and Class II in the US made by Remidio Innovative Solutions Private Limited, registered in EUDAMED on 19 May 2026 (Basic UDI-DI B-08906096520014) and listed in FDA GUDID since 3 Feb 2019 (UDI-DI 08906096520014), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-08906096520014 Basic UDI-DI 08906096520014UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08906096520014 UDI-DI Date3 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08906096520014 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 08906096520014 listed 3 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08906096520014
  2. Registered EUDAMED B-08906096520014

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Fundus On Phone Non Mydriatic EUDAMED
Remidio GUDID
Generic name
Ophthalmic fundus camera
Model / reference
FOP NM-10 EUDAMED
1000010008 EUDAMED
001 GUDID
Primary DI / UDI-DI
08906096520014
Basic UDI-DI
B-08906096520014
FDA product code
PJZ
EMDN code
Q0299 Ophthalmic devices - other
GMDN term
Ophthalmic fundus camera
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1120
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FOP NM-10
1000010008
GUDID
001
Device classEUDAMED
Class IIa
GUDID
Class II
Contains latexEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 08906096520014: EUDAMED states No, FDA GUDID states Yes.

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

Related devices

Category: Ophthalmic fundus cameraSmartphone camera ophthalmic imaging lens

Similar devices in this category

Other devices filed under OPHTHALMIC DEVICES - OTHER.

Other devices from Remidio Innovative Solutions Private Limited

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Properties

  • Single use
  • Contains latex NoEUDAMEDYesGUDID
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)