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Puritan® UniTranz-RT® UT-116

by Puritan Medical Products Company LLC

Ref UT-116

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00609576900037 UDI-DI Date2 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number0609576TMNSCD3L Basic UDI-DI 00609576900037UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Puritan® UniTranz-RT®
Generic Name
General specimen collection kit
Device Name
Collection & Transport System, Non-Sterile
Model / Ref / Catalog
UT-116
Primary DI / UDI-DI
00609576900037
Basic UDI-DI
0609576TMNSCD3L
510(k) Number
FDA Product Code
JSM, LIO
EMDN Code
A1102 Sample collection swabs with transport medium
GMDN Term
General specimen collection kit
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
866.2390, 866.2900
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Related devices

Cleared under the same submission (K113249)

Other devices from Puritan Medical Products Company LLC

See all devices from Puritan Medical Products Company LLC →

Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No