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SentrySuite Software 3.20

by Jaeger Medical GmbH

Ref V-770965

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42508929051912AK4 Basic UDI-DI 04250892907352UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250892907352 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1730-2024 FDA Class I initiated 8 Apr 2024

    Potential of the nozzle separating during patient use.

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  • Withdrawn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
SentrySuite Software
Generic Name
Pulmonary function analysis software, non-interpretive
Device Name
SentrySuite Software Version 3.20
Model / Ref / Catalog
V-770965, 3.20
Primary DI / UDI-DI
04250892907352
Basic UDI-DI
42508929051912AK4
Direct Marketing DI
04250892907352
510(k) Number
FDA Product Code
BZC
EMDN Code
Z12159082 Various pneumology and respiratory physiopathology instruments - software accessories
GMDN Term
Pulmonary function analysis software, non-interpretive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.1880
Special Device Type
Software
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
V-770965
GUDID
3.20
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K150810)

Show all (12)

Other devices from Jaeger Medical GmbH

See all devices from Jaeger Medical GmbH →

Properties

  • Manufacturing Date

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No