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Pharma Mini Port 2 Elbow 6126

by Pharma Systems Ps AB

Ref 6126

Pharma Mini Port 2 Elbow 6126 is a device classified as Class IIa in the EU and Class II in the US made by Pharma Systems Ps AB, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 73400067600075), cleared under FDA 510(k) K202459 on 26 Sep 2021 and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 30734000672202), 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) K202459

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73400067600075 Basic UDI-DI 30734000672202UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30734000672202 UDI-DI Date24 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202459 Date26 Sep 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 73400067600075 registered 28 May 2026 Active
  • FDA 510(k) K202459 decided 26 Sep 2021 Active
  • FDA GUDID UDI-DI 30734000672202 listed 24 Oct 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202459
  2. Listed FDA GUDID 30734000672202
  3. Registered EUDAMED 73400067600075

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  • Withdrawn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
Pharma Mini Port 2 and Elbow EUDAMED
Pharma Mini Port 2 Elbow GUDID
Generic name
Heat/moisture exchanger/microbial medical gas filter
Device name
Heat and Moisture Exchangers (HMEs), Bacterial/Viral Filters (BVFs), and combined HMEF devices
Model / Ref / Catalog
6126
Primary DI / UDI-DI
30734000672202
Basic UDI-DI
73400067600075
510(k) Number
FDA product code
CAH
EMDN code
R040102 Antibacterial and antiviral respiratory filters humidifiers
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
Size
Length — 10.5 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Heat/moisture exchanger/microbial medical gas filter

Cleared under the same submission (K202459)

and 8 more cleared under K202459

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS.

Other devices from Pharma Systems Ps AB

See all devices from Pharma Systems Ps AB →

Properties

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