{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Pharma Systems AB. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/pharma-systems-ab (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/pharma-systems-ab",
    "json_url": "https://devicerts.com/manufacturers/pharma-systems-ab.json",
    "markdown_url": "https://devicerts.com/manufacturers/pharma-systems-ab.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/pharma-systems-ab",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Pharma Systems AB",
    "url": "https://devicerts.com/manufacturers/pharma-systems-ab",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Pharma System AB",
      "Pharma Systems, Inc."
    ],
    "country": null,
    "country_basis": null,
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Pharma Systems AB is a medical device manufacturer, with 157 devices listed in EUDAMED and FDA 510(k) (EU Class IIa; FDA Class I and II) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 157,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 1
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 150
      },
      {
        "registry": "FDA 510(k)",
        "devices": 7
      }
    ],
    "device_classes": [
      {
        "class": "EU Class IIa",
        "devices": 150
      },
      {
        "class": "FDA Class I",
        "devices": 4
      },
      {
        "class": "FDA Class II",
        "devices": 3
      }
    ],
    "top_emdn_categories": [
      {
        "code": "R04",
        "name": "Respiratory filters",
        "url": "https://devicerts.com/categories/emdn/R04",
        "devices": 83
      },
      {
        "code": "R06",
        "name": "Nebulisation and humidification systems",
        "url": "https://devicerts.com/categories/emdn/R06",
        "devices": 39
      },
      {
        "code": "R02",
        "name": "Breathing circuits and catheter mounts",
        "url": "https://devicerts.com/categories/emdn/R02",
        "devices": 28
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [
      {
        "name": "Pharma Systems AB",
        "url": "https://devicerts.com/manufacturers/fda-fei-3005519819",
        "country": "Sweden",
        "devices": 150
      }
    ],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 157,
    "all_devices_url": "https://devicerts.com/manufacturers/pharma-systems-ab",
    "items": [
      {
        "name": "Bact HME Midi Port and PharmaFlex Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-and-pharmaflex-swivel-port-6318ts",
        "model_reference": "6318ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Oxygen Supply",
        "url": "https://devicerts.com/devices/pharma-trach-oxygen-supply-6244s",
        "model_reference": "6244s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and Elbow",
        "url": "https://devicerts.com/devices/bact-hme-port-and-elbow-6025",
        "model_reference": "6025",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Mini Port Angle",
        "url": "https://devicerts.com/devices/pharma-mini-port-angle-6130ts",
        "model_reference": "6130ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Direct Swivel Elbow",
        "url": "https://devicerts.com/devices/pharmaflex-direct-swivel-elbow-5002",
        "model_reference": "5002",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Port and Elbow",
        "url": "https://devicerts.com/devices/bact-trap-port-and-elbow-7013s",
        "model_reference": "7013s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Basic-Oxygen Port and Oxygen Supply Tube",
        "url": "https://devicerts.com/devices/pharma-trach-basic-oxygen-port-and-oxygen-supply-tube-6247",
        "model_reference": "6247",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and PharmaFlex Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-port-and-pharmaflex-swivel-port-6046t",
        "model_reference": "6046t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Straight 15 mm Female",
        "url": "https://devicerts.com/devices/pharmaflex-straight-15-mm-female-5009",
        "model_reference": "5009",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Mini Port 2",
        "url": "https://devicerts.com/devices/bact-trap-mini-port-2-7054ts",
        "model_reference": "7054ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 12 Port",
        "url": "https://devicerts.com/devices/hme-12-port-6072s",
        "model_reference": "6072s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Mini Port Angle",
        "url": "https://devicerts.com/devices/bact-trap-mini-port-angle-7061ts",
        "model_reference": "7061ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Mini Port",
        "url": "https://devicerts.com/devices/pharma-mini-port-6120t",
        "model_reference": "6120t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and Elbow",
        "url": "https://devicerts.com/devices/bact-hme-port-and-elbow-6025t",
        "model_reference": "6025t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Swivel Elbow",
        "url": "https://devicerts.com/devices/pharmaflex-swivel-elbow-5005s",
        "model_reference": "5005s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Midi Port and PharmaFlex Direct Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-and-pharmaflex-direct-swivel-port-6317",
        "model_reference": "6317",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and PharmaFlex Direct Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-port-and-pharmaflex-direct-swivel-port-6044s",
        "model_reference": "6044s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Mini Port and Elbow",
        "url": "https://devicerts.com/devices/pharma-mini-port-and-elbow-6125t",
        "model_reference": "6125t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 12 Port",
        "url": "https://devicerts.com/devices/hme-12-port-6072t",
        "model_reference": "6072t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 10 Port",
        "url": "https://devicerts.com/devices/hme-10-port-6063t",
        "model_reference": "6063t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Suction",
        "url": "https://devicerts.com/devices/pharma-trach-suction-6242s",
        "model_reference": "6242s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 10 Port 2",
        "url": "https://devicerts.com/devices/hme-10-port-2-6065ts",
        "model_reference": "6065ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-HME Midi Port",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-6310s",
        "model_reference": "6310s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Midi Port and Elbow",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-and-elbow-6315ts",
        "model_reference": "6315ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Multipack",
        "url": "https://devicerts.com/devices/pharma-trach-multipack-6245s",
        "model_reference": "6245s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Basic-Oxygen Port",
        "url": "https://devicerts.com/devices/pharma-trach-basic-oxygen-port-6243s",
        "model_reference": "6243s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Midi Port and PharmaFlex Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-and-pharmaflex-swivel-port-6318t",
        "model_reference": "6318t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 10 Port Angle",
        "url": "https://devicerts.com/devices/hme-10-port-angle-6061ts",
        "model_reference": "6061ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Filterpack",
        "url": "https://devicerts.com/devices/pharma-trach-filterpack-6250s",
        "model_reference": "6250s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Swivel Elbow",
        "url": "https://devicerts.com/devices/pharmaflex-swivel-elbow-5005",
        "model_reference": "5005",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-HME Midi Port Angle",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-angle-6320t",
        "model_reference": "6320t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and PharmaFlex Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-port-and-pharmaflex-swivel-port-6046s",
        "model_reference": "6046s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Direct Swivel Port",
        "url": "https://devicerts.com/devices/pharmaflex-direct-swivel-port-5003",
        "model_reference": "5003",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 10 Basic",
        "url": "https://devicerts.com/devices/hme-10-basic-6060s",
        "model_reference": "6060s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Direct Straight 15/15 Male",
        "url": "https://devicerts.com/devices/pharmaflex-direct-straight-15-15-male-5014",
        "model_reference": "5014",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Mini Port",
        "url": "https://devicerts.com/devices/bact-trap-mini-port-7055ts",
        "model_reference": "7055ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Cassette Hook",
        "url": "https://devicerts.com/devices/pharma-trach-cassette-hook-6255s",
        "model_reference": "6255s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-HME Midi Port",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-6310ts",
        "model_reference": "6310ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "PharmaFlex Swivel Port",
        "url": "https://devicerts.com/devices/pharmaflex-swivel-port-5006",
        "model_reference": "5006",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Mini Port 2",
        "url": "https://devicerts.com/devices/bact-trap-mini-port-2-7054t",
        "model_reference": "7054t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Oxygen Supply Gripper-Tube",
        "url": "https://devicerts.com/devices/oxygen-supply-gripper-tube-6260s",
        "model_reference": "6260s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Port and PharmaFlex Direct Swivel Port",
        "url": "https://devicerts.com/devices/bact-hme-port-and-pharmaflex-direct-swivel-port-6044t",
        "model_reference": "6044t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Trach Multi-Function and Oxygen Supply Tube",
        "url": "https://devicerts.com/devices/pharma-trach-multi-function-and-oxygen-supply-tube-6248",
        "model_reference": "6248",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-HME Midi Port Angle",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-angle-6320ts",
        "model_reference": "6320ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact HME Midi Port and Elbow",
        "url": "https://devicerts.com/devices/bact-hme-midi-port-and-elbow-6315s",
        "model_reference": "6315s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pharma Mini Port 2 and Elbow",
        "url": "https://devicerts.com/devices/pharma-mini-port-2-and-elbow-6126t",
        "model_reference": "6126t",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "HME 10 Port",
        "url": "https://devicerts.com/devices/hme-10-port-6063s",
        "model_reference": "6063s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Gas Return System",
        "url": "https://devicerts.com/devices/bact-trap-gas-return-system-7015",
        "model_reference": "7015",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Mini Basic",
        "url": "https://devicerts.com/devices/bact-trap-mini-basic-7050s",
        "model_reference": "7050s",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Bact-Trap Gas Return System",
        "url": "https://devicerts.com/devices/bact-trap-gas-return-system-7015ts",
        "model_reference": "7015ts",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}