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Defibrillation Electrodes P-311-T1

by Tz Medical, Inc.

Ref P-311-T1

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00811331010688 Basic UDI-DI 00811331010688UDI-DIDate3 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00811331010688 UDI-DI Date30 Dec 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Tz Defibrillator Electrodes EUDAMED
Defibrillation Electrodes GUDID
Generic Name
Electrode conductive skin pad, single-use
Model / Reference
P-311-T1
Primary DI / UDI-DI
00811331010688 EUDAMED
10811331010685 GUDID
Basic UDI-DI
B-00811331010688
FDA Product Code
DRO
EMDN Code
Z12030585 Defibrillators - consumables
GMDN Term
Electrode conductive skin pad, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.5550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00811331010688
GUDID
10811331010685
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Tz Medical, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

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