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MolecuLightDX

by MolecuLight Inc.

Ref 1594Model MolecuLightDX

MolecuLightDX (1594) is a patient surgical drape (EU MDR Class IIa; FDA Class II; FDA product code PUI, Drape, Surgical, Exempt) made by MolecuLight Inc, registered in EUDAMED on 1 May 2026 (Basic UDI-DI 628110259TD0032A), cleared under FDA 510(k) K211901 on 21 Jul 2021 and listed in FDA GUDID since 5 Jan 2022 (UDI-DI 00628110259424), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211901↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number628110259TD0032A Basic UDI-DI 00628110259424UDI-DIDate1 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628110259424 UDI-DI Date5 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK211901 Date21 Jul 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 628110259TD0032A registered 1 May 2026 Active
  • FDA 510(k) K211901 decided 21 Jul 2021 Active
  • FDA GUDID UDI-DI 00628110259424 listed 5 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211901
  2. Listed FDA GUDID 00628110259424
  3. Registered EUDAMED 628110259TD0032A

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
MolecuLightDX EUDAMED
MolecuLightDX DarkDrape GUDID
Generic name
Patient surgical drape, single-use
Model / reference
MolecuLightDX EUDAMED
1594 EUDAMED
1973 GUDID
Primary DI / UDI-DI
00628110259424 EUDAMED
00628110259394 GUDID
Basic UDI-DI
628110259TD0032A
FDA product code
PUI
EMDN code
Z12019003 Wound treatment equipment
GMDN term
Patient surgical drape, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4370
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MolecuLightDX
1594
GUDID
1973
Primary DI / UDI-DIEUDAMED
00628110259424
GUDID
00628110259394
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00628110259424; FDA GUDID lists 00628110259394), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
CA-MF-000036119
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from MolecuLight Inc

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Properties

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