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Servo Guard

by Maquet Critical Care AB

Ref 6595487

Servo Guard (6595487) is a device classified as Class IIa in the EU and Class II in the US made by Maquet Critical Care AB, registered in EUDAMED on 6 Aug 2025 (Basic UDI-DI 7325710004568W), cleared under FDA 510(k) K182862 on 21 Oct 2019 (1 earlier submission) and listed in FDA GUDID since 27 Nov 2015 (UDI-DI 07325710004562), active as of 24 Oct 2026.

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

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182862↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7325710004568W Basic UDI-DI 07325710004562UDI-DIDate6 Aug 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK182862 Date21 Oct 2019IssuedStatusActive
United StatesGUDID listing GUDID Number07325710004562 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK030071 Date26 Apr 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7325710004568W registered 6 Aug 2025 Active
  • FDA 510(k) K182862 decided 21 Oct 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07325710004562 listed 27 Nov 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K030071
  2. Listed FDA GUDID 07325710004562
  3. Cleared FDA 510(k) K182862
  4. Registered EUDAMED 7325710004568W

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Servo Guard EUDAMED
Servo Guard 1pcs GUDID
Generic name
Heat/moisture exchanger/microbial medical gas filter
Model / reference
6595487 EUDAMED
6884724 GUDID
Primary DI / UDI-DI
07325710004562
Basic UDI-DI
7325710004568W
510(k) Number
FDA product code
CAH
EMDN code
R040101 Antibacterial and antiviral respiratory filters
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6595487
GUDID
6884724
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.

Manufacturer details

EUDAMED SRN
SE-MF-000001264

Related devices

Category: Secretion suction kit

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS.

Other devices from Maquet Critical Care AB

See all devices from Maquet Critical Care AB →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)