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MacoSeal LIGHT

by Maco Pharma

Ref 9MSLIGHT00

MacoSeal LIGHT (9MSLIGHT00) is a Class I device made by Maco Pharma, registered in EUDAMED on 26 Jun 2024 (Basic UDI-DI 356705TMASL30BC) and listed in FDA GUDID since 27 Aug 2024 (UDI-DI 03567050073097), 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
United StatesGUDID listing GUDID Number03567050073097 UDI-DI Date27 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number356705TMASL30BC Basic UDI-DI Date26 Jun 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 356705TMASL30BC registered 26 Jun 2024 Active
  • FDA GUDID UDI-DI 03567050073097 listed 27 Aug 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 356705TMASL30BC
  2. Listed FDA GUDID 03567050073097

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  • Withdrawn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

Generic name
Blood donor bag tube divider/sealer
Model / reference
9MSLIGHT00
Primary DI / UDI-DI
03567050073097, 03567050074407
Basic UDI-DI
356705TMASL30BC
Direct marketing DI
03567050073097
03567050074407
FDA product code
KSD
EMDN code
Z121780 Blood transfusion instruments - hardware accessories
GMDN term
Blood donor bag tube divider/sealer
Device class
Class I
Regulation number
864.9750
EU registration type
Standard device
EU market of registration
Italy
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000001657

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS.

Other devices from Maco Pharma

See all devices from Maco Pharma →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)