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Invos PMAC71DOC

by Covidien LP

Ref PMAC71DOC

Invos PMAC71DOC is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 0763000B00001306U), cleared under FDA 510(k) K182868 on 8 Jan 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 10884521780170), active as of 2 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001306U Basic UDI-DI 10884521780170UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521780170 UDI-DI Date31 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182868 Date8 Jan 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001306U registered 17 Aug 2026 Active
  • FDA 510(k) K182868 decided 8 Jan 2019 Active
  • FDA GUDID UDI-DI 10884521780170 listed 31 Jul 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1732-2024 FDA Class II initiated 9 Jan 2024

    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Timeline

4 dated events

  1. Cleared FDA 510(k) K182868
  2. Listed FDA GUDID 10884521780170
  3. Recall initiated FDA recalls Z-1732-2024
  4. Registered EUDAMED 0763000B00001306U

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Invos
Generic name
Noninvasive device battery charger
Device name
Invos PM7100 Re-Usable Sensor Cable
Model / reference
PMAC71DOC
Primary DI / UDI-DI
10884521780170
Basic UDI-DI
0763000B00001306U
510(k) Number
FDA product code
MUD
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Noninvasive device battery charger
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Noninvasive device battery charger

Cleared under the same submission (K182868)

and 8 more cleared under K182868

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

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See all devices from Covidien LP →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)