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Halo EU 1216-10020

by Medical Devices, Inc.

Ref 1216-10020

Halo EU 1216-10020 is a device classified as Class IIb in the EU and Class I in the US made by Medical Devices, Inc., registered in EUDAMED on 4 May 2026 (Basic UDI-DI 08500106081216-10000NW) with CE/MDR certificate 28620178174 valid until 5 Jun 2029 and listed in FDA GUDID since 31 May 2023 (UDI-DI 00850010608488), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

5 Jun 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08500106081216-10000NW Basic UDI-DI 00850010608488UDI-DIDate4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850010608488 UDI-DI Date31 May 2023ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08500106081216-10000NW registered 4 May 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850010608488 listed 31 May 2023 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Listed FDA GUDID 00850010608488
  2. Certificate issued EUDAMED 28620178174
  3. Registered EUDAMED 08500106081216-10000NW
  4. Certificate expires EUDAMED 28620178174

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  • Withdrawn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
Halo Vent 2 Pack IFAK, 2 Halo Vents 5.5"x7.5" EUDAMED
Halo GUDID
Generic name
Wound hydrogel dressing, non-antimicrobial
Model / Ref / Catalog
1216-10020, EU 1216-10020, EU
Primary DI / UDI-DI
00850010608488, 00850010608082
Basic UDI-DI
08500106081216-10000NW
FDA product code
NAD
EMDN code
M04040501 Hydrogel dressings, non-combined
GMDN term
Wound hydrogel dressing, non-antimicrobial
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4020
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution (UDI-DI 00850010608488)
Not in Commercial Distribution (UDI-DI 00850010608082)

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

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

Related devices

Category: Wound hydrogel dressing, non-antimicrobial

Similar devices in this category

Other devices filed under HYDROGEL DRESSINGS, NON-COMBINED.

Other devices from Medical Devices, Inc.

See all devices from Medical Devices, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)