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HME 10 Basic 6060

by Pharma Systems Ps AB

Ref 6060

HME 10 Basic 6060 is a device classified as Class IIa in the EU and Class I in the US made by Pharma Systems Ps AB, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 73400067600075) and listed in FDA GUDID since 13 Jan 2023 (UDI-DI 30734000671342), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73400067600075 Basic UDI-DI 30734000671342UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30734000671342 UDI-DI Date13 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 73400067600075 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 30734000671342 listed 13 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30734000671342
  2. Registered EUDAMED 73400067600075

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  • Withdrawn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
HME 10 Basic
Generic name
Electrocautery system generator, line-powered
Device name
Heat and Moisture Exchangers (HMEs), Bacterial/Viral Filters (BVFs), and combined HMEF devices
Model / Ref / Catalog
6060
Primary DI / UDI-DI
30734000671342
Basic UDI-DI
73400067600075
FDA product code
BYD
EMDN code
R060299 Humidification systems - other
GMDN term
Electrocautery system generator, line-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5375
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
Size
Length — 7.3 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Electrocautery system generator, line-powered

Other devices from Pharma Systems Ps AB

See all devices from Pharma Systems Ps AB →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)