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Hema

by Aso LLC 2 variants

Part of a family of 114 devices: see the family page

Ref HE-0818584Model 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378

Hema (HE-0818584) is a Class IIa device made by Aso LLC, registered in EUDAMED on 31 Jan 2024 (Basic UDI-DI 0017276M226M3), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0017276M226M3 Basic UDI-DI 08721245263846UDI-DIDate31 Jan 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Non-Sterile Hydrocolloid Bandages
Model / reference
40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378, HE-0818584
Primary DI / UDI-DI
08721245263846
Basic UDI-DI
0017276M226M3
EMDN code
M04040301 Hydrocolloid dressings, non-combined
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008641
Authorised representative
Aso Europe BV NL-AR-000004377

Similar devices in this category

Other devices filed under HYDROCOLLOID DRESSINGS, NON-COMBINED.

Other devices from Aso LLC

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Properties

Other properties (14, all answered No)