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Fin-ceramica faenza SpA

Active in EUDAMED

Italyfrom SRN EUDAMED FDA SRN IT-MF-000023496 FEI 3006130229

Devices
69
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

4 of 4 in force.

See certificates

Market reach

European Union
EUDAMED actor, 4 certificates
United States
FDA establishment

What Fin-ceramica faenza SpA makes

Fin-ceramica faenza spa manufactures medical devices composed of ceramic biomaterials designed for the regeneration of bone and cartilage tissues. Their product portfolio includes RegenOss, ENGIpore, MaioRegen, and SINTlife, which are utilized in surgical and neurosurgical applications.

These devices are classified as Class III medical devices and are listed in EUDAMED. The company is based in Italy.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue69

Newest first, rows 1-50 of 69

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  • MaioRegen Mini-Arthro Kit Ref 33109

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • RegenOss ABR Ref 01600831

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • RegenOss ABR Ref 01600830

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • RegenOss Ortho Ref 01600815

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015006-19-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-50-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Oval Ref 01600406

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • RegenOss Ortho Ref 01600816

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • RegenOss Spine Ref 01600821

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Prime Oval Ref 01600295

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Ref 01600405

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015006-20-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015006-25-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-51-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Ref 01600287

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-77-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-23-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-21-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • SINTlife Spine Ref PFS015057-04-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Prime Oval Ref 01600298

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-75-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Ref 01600282

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • MaioRegen Prime Oval Ref 01600297

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015008-03-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Ref 01600403

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • MaioRegen Slim Oval Ref 01600306

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Ref 01600400

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Ref 01600402

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015008-01-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-30-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Oval Ref 01600301

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • SINTlife Ortho Ref PFS015056-00-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015008-02-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Oval Ref 01600408

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • MaioRegen Prime Ref 01600286

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-32-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Oval Ref 01600303

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • SINTlife Ortho Ref PFS015056-01-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RegenOss Ortho Ref 01600818

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • SINTlife Spine Ref PFS015057-08-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-24-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Oval Ref 01600409

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-40-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Oval Ref 01600304

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Prime Oval Ref 01600299

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • MaioRegen Prime Oval Ref 01600296

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Slim Ref 01600290

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • MaioRegen Chondro+ Ref 01600404

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

  • ENGIpore Ortho Ref PFS015005-52-00

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • MaioRegen Prime Ref 01600275

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:III

Rows 1-50 of 69

Showing 1-50 of 69

Company details

EUDAMED SRN
IT-MF-000023496
FDA FEI number
3006130229
EU VAT number
01025400399
EUDAMED status
Active
EUDAMED registered name
Fin-ceramica faenza spa
Registered address
177/3, Legal site: via Granarolo, 48018, Faenza, Italy
Phone
+39 0546 607311
PRRC contact
Roberta Martinetti(public in EUDAMED)

EUDAMED certificates4

4 certificates4 valid, 0 expiredMDR 4next expiry 12 Mar 2028

EUDAMED certificates (4)

ISTITUTO SUPERIORE DI SANITA' 0373 3 certificates

  • CSQ0008230326 Active

    Quality management system EU MDR

    Issued
    31 Mar 2026
    Expires
    12 Mar 2028
  • CVD000423 Active

    Technical documentation EU MDR

    Issued
    13 Mar 2023
    Expires
    12 Mar 2028
  • CVD0005230226 Active

    Technical documentation EU MDR

    Issued
    5 Mar 2026
    Expires
    12 Mar 2028

DNV Product Assurance AS 2460 1 certificate

  • C787129 Active

    Quality management system EU MDR

    Issued
    11 Mar 2026
    Expires
    10 Mar 2031

FDA establishments1

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

  • Finceramica Faenza SpA US

From the company website

Read 18 Oct 2026

Researches, develops, manufactures, and markets innovative medical devices made of ceramic biomaterials for the regeneration of damaged bone and cartilage tissues. The developed technologies are applied in the fields of neurosurgery and surgery.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Fin-ceramica faenza spa have in the registry?

The registry currently lists 69 devices for Fin-ceramica faenza spa. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fin-ceramica faenza spa's devices?

Among its 50 most recently registered devices, Fin-ceramica faenza spa has devices listed in EUDAMED (50 devices).

What risk classes do Fin-ceramica faenza spa's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Fin-ceramica faenza spa's devices are Class I and Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Fin-ceramica faenza spa?

EUDAMED lists 4 certificates for Fin-ceramica faenza spa (quality management system; technical documentation) under MDR. 4 are recorded with the status issued. The most recent was issued on 2026-03-31.

What are the newest devices from Fin-ceramica faenza spa in the registry?

The most recently registered devices listed for Fin-ceramica faenza spa include MaioRegen Mini-Arthro Kit, RegenOss ABR, RegenOss Ortho and ENGIpore Ortho.

Which FDA establishments are linked to Fin-ceramica faenza spa?

1 FDA establishment is linked to Fin-ceramica faenza spa in the registry; they are listed on the company page.

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