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Invos PMAC71RIC

by Covidien LP

Ref PMAC71RIC

Invos PMAC71RIC 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) K211561 on 5 Dec 2021 (1 earlier submission) and listed in FDA GUDID since 13 Sep 2021 (UDI-DI 10884521806436), active as of 25 Oct 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211561

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001306U Basic UDI-DI 10884521806436UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211561 Date5 Dec 2021DecidedStatusActive
United StatesGUDID listing GUDID Number10884521806436 UDI-DI Date13 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001306U registered 17 Aug 2026 Active
  • FDA 510(k) K211561 decided 5 Dec 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521806436 listed 13 Sep 2021 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1732-2024 FDA Class II initiated 9 Jan 2024
    • Ongoing Z-1731-2024 FDA Class II initiated 9 Jan 2024

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K182868
  2. Listed FDA GUDID 10884521806436
  3. Cleared FDA 510(k) K211561
  4. Recall initiated FDA recalls Z-1732-2024
  5. Recall initiated FDA recalls Z-1731-2024
  6. 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  • Withdrawn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
Electrical-only medical device connection cable, reusable
Device name
Invos PM7100 Re-Usable Sensor Cable
Model / reference
PMAC71RIC
Primary DI / UDI-DI
10884521806436
Basic UDI-DI
0763000B00001306U
510(k) Number
FDA product code
MUD
EMDN code
Z1203020407 Subcutaneous oximeters
GMDN term
Electrical-only medical device connection cable, reusable
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: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K182868)

and 8 more cleared under K182868

Cleared under the same submission (K211561)

and 8 more cleared under K211561

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

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See all devices from Covidien LP →

Properties

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