Skip to content

Remidio PSL - D20

by Remidio Innovative Solutions Private Limited

Ref 1000010013Model PSL-D20

Remidio PSL - D20 (3231680018) is an ophthalmic examination slit lamp (EU MDR Class I; FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Remidio Innovative Solutions Private Limited, registered in EUDAMED on 18 May 2026 (Basic UDI-DI 890609652PSLD20QG) and listed in FDA GUDID since 26 Nov 2021 (UDI-DI 08906096520045), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number890609652PSLD20QG Basic UDI-DI 08906096520045UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08906096520045 UDI-DI Date26 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 890609652PSLD20QG registered 18 May 2026 Active
  • FDA GUDID UDI-DI 08906096520045 listed 26 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08906096520045
  2. Registered EUDAMED 890609652PSLD20QG

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  • Withdrawn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 Portable Slit Lamp EUDAMED
Remidio GUDID
Generic name
Ophthalmic examination slit lamp
Model / Ref / Catalog
PSL-D20 EUDAMED
1000010013 EUDAMED
PSL - D20 GUDID
3231680018 GUDID
Primary DI / UDI-DI
08906096520045
Basic UDI-DI
890609652PSLD20QG
FDA product code
HJO
EMDN code
Z12120108 Slit lamps
GMDN term
Ophthalmic examination slit lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1850
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PSL-D20
1000010013
GUDID
PSL - D20
Device classEUDAMED
Class I
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 08906096520045: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I 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 examination slit lamp

Similar devices in this category

Other devices filed under SLIT LAMPS.

Other devices from Remidio Innovative Solutions Private Limited

See all devices from Remidio Innovative Solutions Private Limited →

Properties

  • Contains latex NoEUDAMEDYesGUDID
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)