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Pinnacle Sensor Cover 3736C

by Metrex Research

Part of a family of 23 devices: see the family page

Ref 3736

Pinnacle Sensor Cover 3736C is a device classified as Class I in the EU and Class II in the US made by Metrex Research, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 0615375000002QJ) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00615375004555), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0615375000002QJ Basic UDI-DI 00615375004555UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00615375004555 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0615375000002QJ registered 26 May 2026 Active
  • FDA GUDID UDI-DI 00615375004555 listed 31 Aug 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00615375004555
  2. Registered EUDAMED 0615375000002QJ

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  • Withdrawn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
Pinnacle Sensor Cover
Generic name
Instrument/equipment drape, single-use, non-sterile
Device name
Barriers
Model / reference
3736 EUDAMED
3736C GUDID
Description
Digital XRay Sensor Sleeves Disposable
Primary DI / UDI-DI
00615375004555
Basic UDI-DI
0615375000002QJ
FDA product code
MMP
EMDN code
T030102 Cover sheaths, instruments and equipments
GMDN term
Instrument/equipment drape, single-use, non-sterile
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
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
3736
GUDID
3736C
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Instrument/equipment drape, single-use, non-sterile

Similar devices in this category

Other devices filed under COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS.

Other devices from Metrex Research

See all devices from Metrex Research →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)