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PC Electrometer (TNC) 1014400Z

by Sun Nuclear Corporation

Ref 1014

PC Electrometer (TNC) 1014400Z (10140001Z) is a device classified as Class IIb in the EU and Class II in the US made by Sun Nuclear Corporation, registered in EUDAMED on 12 Jun 2025 (Basic UDI-DI 506060888DPPCElec6N) with CE/MDR certificate 28620200479 valid until 6 Jan 2028, cleared under FDA 510(k) K092019 on 15 Sep 2009 and listed in FDA GUDID since 10 Apr 2019 (UDI-DI 05060608880218), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

6 Jan 2028

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K092019

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506060888DPPCElec6N Basic UDI-DI Date12 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608880218 UDI-DI Date10 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092019 Date15 Sep 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506060888DPPCElec6N registered 12 Jun 2025 Active· +1 more in the status table
  • FDA 510(k) K092019 decided 15 Sep 2009 Active
  • FDA GUDID UDI-DI 05060608880218 listed 10 Apr 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K092019
  2. Listed FDA GUDID 05060608880218
  3. Certificate issued EUDAMED 28620200479
  4. Registered EUDAMED 506060888DPPCElec6N
  5. Certificate expires EUDAMED 28620200479

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  • Withdrawn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
PC Electrometer EUDAMED
PC Electrometer (TNC) GUDID
PC Electrometer Reference Class Dual-Channel Electrometer (BNC) GUDID
Generic name
Radiation electrometer
Model / Ref / Catalog
1014 EUDAMED
1014400Z GUDID
1014300Z GUDID
10140001Z GUDID
1014000-0Z GUDID
Primary DI / UDI-DI
05060608880218, 05060608880065
Basic UDI-DI
506060888DPPCElec6N
510(k) Number
FDA product code
IYE
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Radiation electrometer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1014
GUDID
1014400Z
1014300Z
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Radiation electrometer

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Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

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Properties

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