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Biometry Probe TP-01 / TP-01-b

by Quantel Medical

Part of a family of 7 devices: see the family page

Ref Tp-01-b

Biometry Probe TP-01 / TP-01-b is a device classified as Class IIa in the EU and Class II in the US made by Quantel Medical, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 37005426ABSOLUAP) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625095), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number37005426ABSOLUAP Basic UDI-DI 03700542625095UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625095 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37005426ABSOLUAP registered 28 May 2026 Active
  • FDA GUDID UDI-DI 03700542625095 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700542625095
  2. Registered EUDAMED 37005426ABSOLUAP

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  • Withdrawn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
Biometry Probe 11MHz (Tp-01-b) EUDAMED
Biometry Probe GUDID
Generic name
Ophthalmic ultrasound imaging transducer
Device name
Absolu
Model / reference
Tp-01-b EUDAMED
TP-01 / TP-01-b GUDID
Primary DI / UDI-DI
03700542625095
Basic UDI-DI
37005426ABSOLUAP
FDA product code
ITX
EMDN code
Z11040107 Echophthalmographs
GMDN term
Ophthalmic ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Tp-01-b
GUDID
TP-01 / TP-01-b
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Ophthalmic ultrasound imaging transducer

Similar devices in this category

Other devices filed under ECHOPHTHALMOGRAPHS.

Other devices from Quantel Medical

See all devices from Quantel Medical →

Properties

  • Measuring function
  • Serial number
Other properties (23, all answered No)