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NA Soft X-ray chamber 0.005 cm³

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

Ref TW34013

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-+EPTWTW340130 Basic UDI-DI +EPTWTW340130UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EPTWTW340130 UDI-DI Date27 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  • Withdrawn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
Ionization chamber radiation measuring probe
Device Name
Soft X-ray chamber 0.005 cm³
Model / Ref / Catalog
TW34013, Soft X-ray chamber 0.005 cm³
Primary DI / UDI-DI
+EPTWTW340130 EUDAMED
EPTWTW340130 GUDID
Basic UDI-DI
B-+EPTWTW340130
510(k) Number
FDA Product Code
IYE
EMDN Code
Z119002 Dosimeters
GMDN Term
Ionization chamber radiation measuring probe
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
TW34013
GUDID
Soft X-ray chamber 0.005 cm³
Primary DI / UDI-DIEUDAMED
+EPTWTW340130
GUDID
EPTWTW340130
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Ionization chamber radiation measuring probe

Cleared under the same submission (K961208)

Show all (12)

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • 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