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Thermode CHEPS TSA 2

by Medoc Corp.

Part of a family of 9 devices: see the family page

Ref AS 00420Model AS 00176

Thermode CHEPS TSA 2 (AS 00420) is a thermotester (EU MDR Class IIa; FDA Class I; FDA product code LQW, Test, Temperature Discrimination) made by Medoc Corp., registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI 72901030300006F8) and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 07290103039219), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number72901030300006F8 Basic UDI-DI 07290103039219UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290103039219 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 72901030300006F8 registered 5 Aug 2026 Active
  • FDA GUDID UDI-DI 07290103039219 listed 20 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290103039219
  2. Registered EUDAMED 72901030300006F8

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  • Withdrawn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
Thermode CHEPS (MP118.4W) EUDAMED
Thermode CHEPS GUDID
Generic name
Thermotester, diagnostic
Device name
TSA 2 Thermode 30x30
Model / Ref / Catalog
AS 00176, AS 00420, TSA 2
Primary DI / UDI-DI
07290103039219
Basic UDI-DI
72901030300006F8
Direct marketing DI
07290103039219
FDA product code
LQW
EMDN code
V030207 Sensitivity measurements devices not included in other classes
GMDN term
Thermotester, diagnostic
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
882.1200
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AS 00176
AS 00420
GUDID
TSA 2
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Thermotester, diagnostic

Similar devices in this category

Other devices filed under CLINICAL DIMENSIONAL PARAMETERS MEASURING DEVICES.

Other devices from Medoc Corp.

See all devices from Medoc Corp. →

Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)