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Halo 1216-10004

by Medical Devices, Inc.

Ref 1216-10004

Halo 1216-10004 is a Class I device made by Medical Devices, Inc., registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-00850010608044) and listed in FDA GUDID since 2 Mar 2021 (UDI-DI 00850010608044), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00850010608044 Basic UDI-DI 00850010608044UDI-DIDate26 Jun 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00850010608044 Basic UDI-DI 00850010608044UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850010608044 UDI-DI Date2 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850010608044 registered 26 Jun 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850010608044 listed 2 Mar 2021 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850010608044
  2. Registered EUDAMED B-00850010608044

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Halo XL, Flat Package, 1 Halo XL with CE Mark EUDAMED
Halo XL, Flat Package, 1 Halo XL EUDAMED
Halo GUDID
Generic name
Wound hydrogel dressing, non-antimicrobial
Device name
Halo Seal
Model / Ref / Catalog
1216-10004
Primary DI / UDI-DI
00850010608044
Basic UDI-DI
B-00850010608044, 08500106081216-20000P9
FDA product code
NAD
EMDN code
M04040501 Hydrogel dressings, non-combined
GMDN term
Wound hydrogel dressing, non-antimicrobial
Device class
Class I
Regulation number
878.4020
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

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)