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Formlabs Ohio Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000002761

Devices
28
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
Authorised rep.
Advena LimitedMT

What Formlabs Ohio Inc. makes

Formlabs Ohio Inc. makes dental resins, including Premium Teeth Resin, Dental LT Clear V2 Resin, Surgical Guide Resin, Dental LT Comfort Resin, and Custom Tray Resin. These products are types of dental materials used in various applications.

The company's portfolio is regulated under Class I, Class IIa, and U device classes, and its devices are listed in the Eudamed and FDA 510(k) registries. The company is based in the US.

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

Catalogue28

Newest first, rows 1-28 of 28

Search and filter all 28 devices
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  • H-0600 Resin RS-RPS-H6PR-01

    Class I
    None GUDID I

  • Denture Base Resin V2 FLDBDP02

    Class II
    Active CE MDR EUDAMEDGUDID II

  • Denture Base Resin V2 Ref K262300

    Class II
    Active 510(k) 510(k) II

  • Denture Base Resin V2 Ref FLDBOP02

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Denture Base Resin V2 Ref FLDBLP02

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Dental LT Comfort Ref FLDLC001

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Premium Teeth Resin Ref FLPTB101

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Dental LT Clear V2 Resin Ref FLDLCL02

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Dental LT Clear V2 Resin Ref FLDLCL02

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Surgical Guide Resin Ref FLSGAM01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Premium Teeth Resin Ref FLPTA201

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Premium Teeth Resin Ref FLPTA301

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Surgical Guide Resin Ref FLSGAM01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Dental LT Comfort Resin Ref K232087

    Unclassified
    Active CE MDR 510(k) 510(k) —

  • Premium Teeth Resin Ref FLPTA301

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Premium Teeth Resin Ref FLPTB101

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Custom Tray Resin Ref FLCTBL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Dental LT Clear V2 Resin Ref FLDLCL02

    Class IIa
    Active CE MDR 510(k) EUDAMEDGUDID IIa

  • IBT Resin Ref FLIBCL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • IBT Flex Resin Ref FLIBFL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Premium Teeth Resin Ref FLPTBL01

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Custom Tray Resin Ref FLIBFL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • IBT Flex Resin Ref FLIBFL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Dental LT Comfort Ref FLDLCO11

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Custom Tray Resin Ref FLIBFL01

    Class I
    Active CE MDR EUDAMEDGUDID I

  • Premium Teeth Resin Ref FLPTBL01

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Dental LT Comfort Ref FLDLC001

    Class IIa
    Active CE MDR EUDAMEDGUDID IIa

  • Premium Teeth Resin Ref FLPTA201

    Class IIa
    Active CE MDR 510(k) EUDAMEDGUDID IIa

Rows 1-28 of 28

Company details

EUDAMED SRN
US-MF-000002761
DUNS number
106744280
EUDAMED status
Active
EUDAMED registered name
Formlabs Ohio Inc.
EUDAMED abbreviated name
Formlabs
Registered address
27800 Lemoyne Rd, 43447, Millbury, Ohio, United States
PRRC contact
Nathan Alt(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 12 Jun 2027

EUDAMED certificates (1)

Intertek Medical Notified Body AB 2862 1 certificate

  • 28620124904 Issued

    Quality management system EU MDR

    Issued
    9 Mar 2026
    Expires
    12 Jun 2027

Frequently asked questions

How many devices does FORMLABS OHIO INC. have in the registry?

The registry currently lists 28 devices for FORMLABS OHIO INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list FORMLABS OHIO INC.'s devices?

Among its 28 most recently registered devices, FORMLABS OHIO INC. has devices listed in EUDAMED (25 devices), FDA 510(k) (2 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do FORMLABS OHIO INC.'s devices fall under?

Among its 28 most recently registered devices, the classes recorded for FORMLABS OHIO INC.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for FORMLABS OHIO INC.?

EUDAMED lists 1 certificate for FORMLABS OHIO INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-03-09.

What are the newest devices from FORMLABS OHIO INC. in the registry?

The most recently registered devices listed for FORMLABS OHIO INC. include H-0600 Resin RS-RPS-H6PR-01, Denture Base Resin V2 FLDBDP02, Denture Base Resin V2 and Dental LT Comfort.

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