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ECG Harness

by Remote Diagnostic Technologies Ltd.

Ref 01-2001 / 989706011050Model 01-2001

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 linked in EUDAMED

A group certificate may exist

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 Number506047244BM733VC Basic UDI-DI 05060472440464UDI-DIDate6 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060472440464 UDI-DI Date16 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
ECG Harness EUDAMED
Tempus IC2 GUDID
Generic Name
Multiple vital physiological parameter monitoring system, clinical
Device Name
IC2 12-Lead ECG Harness
Model / Reference
01-2001, 01-2001 / 989706011050
Primary DI / UDI-DI
05060472440464
Basic UDI-DI
506047244BM733VC
510(k) Number
FDA Product Code
MWI
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
GMDN Term
Multiple vital physiological parameter monitoring system, clinical
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2300
EU market of registration
Luxembourg
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000002127
Authorised representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Related devices

Category: Electrocardiographic lead set, reusable

Other devices from Remote Diagnostic Technologies Limited

See all devices from Remote Diagnostic Technologies Limited →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No