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Pharma Mini Basic 6100

by Pharma Systems Ps AB

Ref 6100

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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 Number73400067600075 Basic UDI-DI 30734000671182UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30734000671182 UDI-DI Date24 Oct 2023ListedStatusListed 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Pharma Mini Basic
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
6100
Primary DI / UDI-DI
30734000671182
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 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 II

Related devices

Category: Heat/moisture exchanger/microbial medical gas filter

Cleared under the same submission (K202459)

Show all (12)

Other devices from Pharma Systems Ps AB

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No