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Na Tandem

by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 2 variants

Ref T10015

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EPTWT100150 Basic UDI-DI +EPTWT100150UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWT100150 UDI-DI Date26 Apr 2017ListedStatusListed 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 23 Oct 2026.

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  • Withdrawn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

Generic Name
Radiation electrometer
Device Name
Tandem
Model / Ref / Catalog
T10015, TANDEM
Primary DI / UDI-DI
+EPTWT100150 EUDAMED
EPTWT100150 GUDID
Basic UDI-DI
B-+EPTWT100150
510(k) Number
FDA Product Code
IYE
EMDN Code
Z119002 Dosimeters
GMDN Term
Radiation electrometer
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
T10015
GUDID
TANDEM
Primary DI / UDI-DIEUDAMED
+EPTWT100150
GUDID
EPTWT100150
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Radiation electrometer

Cleared under the same submission (K954165)

Show all (12)

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: 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