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ZOLL Patch

by ZOLL Manufacturing Corporation

Ref 10A1067

ZOLL Patch (10A1067) is a device classified as Class IIa in the EU and Class II in the US made by ZOLL Manufacturing Corporation, registered in EUDAMED on 17 Jun 2026 (Basic UDI-DI 0855778005K172510WG) with CE/MDR certificate 3903097CE01 valid until 1 Sep 2028, cleared under FDA 510(k) K190939 on 19 Dec 2019 (1 earlier submission) and listed in FDA GUDID since 17 May 2019 (UDI-DI 00855778005616), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

1 Sep 2028

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K190939

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0855778005K172510WG Basic UDI-DI 00855778005616UDI-DIDate17 Jun 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190939 Date19 Dec 2019DecidedStatusActive
United StatesGUDID listing GUDID Number00855778005616 UDI-DI Date17 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0855778005K172510WG registered 17 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K190939 decided 19 Dec 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00855778005616 listed 17 May 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903097CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    19 May 2026
    Expires
    1 Sep 2028
    Reason
    Other

Timeline

6 dated events

  1. Cleared FDA 510(k) K172510
  2. Listed FDA GUDID 00855778005616
  3. Cleared FDA 510(k) K190939
  4. Certificate issued EUDAMED 3903097CE01
  5. Registered EUDAMED 0855778005K172510WG
  6. Certificate expires EUDAMED 3903097CE01

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
μCor Heart Failure and Arrhythmia Management System (HFAMS) EUDAMED
ZOLL Patch GUDID
Generic name
Wearable multiple vital physiological parameter monitoring system
Model / Ref / Catalog
10A1067, Patch
Primary DI / UDI-DI
00855778005616 EUDAMED
00855778005258 GUDID
Basic UDI-DI
0855778005K172510WG
510(k) Number
FDA product code
DSB, MHX, DSI
EMDN code
Z12050801 Complete cardiac telemetry systems
GMDN term
Wearable multiple vital physiological parameter monitoring system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2770, 870.1025
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10A1067
GUDID
Patch
Primary DI / UDI-DIEUDAMED
00855778005616
GUDID
00855778005258
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00855778005616; FDA GUDID lists 00855778005258), 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.

Related devices

Category: Wearable multiple vital physiological parameter monitoring system

Cleared under the same submission (K172510)

Cleared under the same submission (K190939)

Similar devices in this category

Other devices filed under CARDIAC TELEMETRY INSTRUMENTS.

Other devices from ZOLL Manufacturing Corporation

See all devices from ZOLL Manufacturing Corporation →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)