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Adhesive Belt S Ace-ADH0A1P0

by Timpel S/A

Ref ACE-ADL0A1P0

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7898959841ADDERE3Y Basic UDI-DI 07908715700464UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07908715700464 UDI-DI Date24 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Adhesive Belt - Size S EUDAMED
Adhesive Belt S GUDID
Generic Name
Thoracic electrical impedance electrode array conductive skin adhesive tape
Device Name
Addere
Model / Reference
ACE-ADL0A1P0 EUDAMED
ACE-ADH0A1P0 GUDID
Primary DI / UDI-DI
07908715700464
Basic UDI-DI
7898959841ADDERE3Y
Direct Marketing DI
07908715700464
510(k) Number
FDA Product Code
QEB
EMDN Code
V9015 Electrodes and probes cutaneous conductive substances
GMDN Term
Thoracic electrical impedance electrode array conductive skin adhesive tape
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.1505
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ACE-ADL0A1P0
GUDID
ACE-ADH0A1P0
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K250464)

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No