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Delta Med SpA

Active in EUDAMED

Italyfrom SRN EUDAMED FDA SRN IT-MF-000027962 FEI 3006846316

Devices
1,655
Registrations
EUDAMEDFDA
FDA recalls
1111 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

What Delta Med SpA makes

Delta Med Spa makes peripheral intravenous cannulas, peripheral vascular catheters, ophthalmic surgical procedure kits (non-medicated, single-use), and venous butterfly needles or sets. Specific device examples include Deltaven Fast Flash and DELTAVEN.

The company's devices are classified as Class I, Class II, and Class IIa, and are listed in the EUDAMED and FDA UDI registries. Delta Med Spa is based in Italy.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1,655

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IT-MF-000027962
SRN (system / procedure pack)
IT-PR-000056955
FDA FEI number
3006846316
DUNS number
444776777
EU VAT number
01693020206
EUDAMED status
Active
EUDAMED registered name
Delta Med SPA
Registered address
20, via Guido Rossa, 46019, Viadana, Italy
PRRC contact
Paolo Abbreviato(public in EUDAMED)

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 11 recalls initiated by DELTA MED SPA, initiated on 2021-06-21. By recorded status: 11 ongoing. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 11
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 11 recalls.

  • 2021

    • 21 Jun 2021 Z-2295-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K171530
    • 21 Jun 2021 Z-2296-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K200373
    • 21 Jun 2021 Z-2297-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K171530
    • 21 Jun 2021 Z-2298-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K171530
    • 21 Jun 2021 Z-2299-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
    • 21 Jun 2021 Z-2300-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
    • 21 Jun 2021 Z-2301-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
    • 21 Jun 2021 Z-2302-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
    • 21 Jun 2021 Z-2303-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
    • 21 Jun 2021 Z-2304-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K121007
Show all 11 recalls

  • 2021

    • 21 Jun 2021 Z-2305-2021 Class II Ongoing Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Distribution: US Nationwide distribution in the states of FL and MN. Submission number: K200373

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • DeltaMed GmbH FRIEDBERG Hesse · DE FEI 3002789526

Frequently asked questions

How many devices does DELTA MED SPA have in the registry?

The registry currently lists 1655 devices for DELTA MED SPA. Devices recorded under merged duplicate company entries are counted once.

Which registries list DELTA MED SPA's devices?

Among its 50 most recently registered devices, DELTA MED SPA has devices listed in EUDAMED (29 devices) and FDA GUDID (21 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do DELTA MED SPA's devices fall under?

Among its 50 most recently registered devices, the classes recorded for DELTA MED SPA's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for DELTA MED SPA?

FDA recall records list 11 recalls initiated by DELTA MED SPA, the most recent initiated on 21 Jun 2021. 11 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from DELTA MED SPA in the registry?

The most recently registered devices listed for DELTA MED SPA include PICC Assembled System, Assembled Midline Catheter System, Cesarean section assembled system and Kit PICC Power Injectable.

Which FDA establishments are linked to DELTA MED SPA?

1 FDA establishment is linked to DELTA MED SPA in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.