Skip to content

Spident

Active in EUDAMED
Also registered as SPIDENT CO., LTD.

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000008691

Spident is a medical device manufacturer based in South Korea, with 318 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa and I; FDA Class II) as of 12 Nov 2026.

Devices
318
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • EUDAMED 313
  • FDA GUDID 61
  • FDA 510(k) 6

A device listed in two registries counts in both.

Device classes
  • EU Class IIa 299
  • EU Class I 14
  • FDA Class II 5
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000008691

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
United States
FDA establishment
Authorised rep.
AR Experts B.V.NL

Catalogue318

Newest first, rows 1-50 of 318

Search and filter all 318 devices
Skip device list

  • OrthoFit Aligner (OrthoFit Aligner A2) Ref K262433

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EsFlow PLUS BW Ref #3306BWP01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS OW Ref #3306OWP01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • supraCXN EsCem A3 Ref #3805A3UCG

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanohybrid Composite+ A1 Ref 3136570

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanofil+ C2 Ref 3136566

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS BW Ref #3306BWP04

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B AO3 Ref #E1204AO3

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS OW Ref #3306OWP02

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS Injectable BW Ref #3306BA2P01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Composite Universal Fotopolimerizable Capsule OA3 Ref 63630

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B Sample A1 Ref #E1204A1SA

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanohybrid Composite+ A3.5 Ref 3136573

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS Injectable BW Ref #3306BA2P04

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Flow B2 Ref Ρ985

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

  • Flow A1 Ref Ρ981

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

  • EsTemp C&B B1 Ref #E1204B1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B C2 Ref #E1204C2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B A1 Ref #E1204A1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B A2 Ref #E1204A2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanohybrid Composite+ B2 Ref 3136576

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B A3 Ref #E1204A3

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B TW Ref #E1204TW

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Flow A3.5 Ref Ρ984

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

  • Nanohybrid Composite+ B1 Ref 3136575

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanofil+ A3.5 Ref 3136562

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsTemp C&B Sample A2 Ref #E1204A2SA

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Flow B1 Ref P986

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

  • OrthoFit Ref K261129

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EsTemp Implant Ref K262983

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Core·it Dual Ref K262982

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vioseal X Ref K262050

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nanohybrid Composite+ A3 Ref 3136572

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS Injectable OW Ref #3306CA2P04

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanohybrid Composite+ AO2 Ref 3136579

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsBond Ref #3702P01

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

  • EsFlow PLUS Injectable OW Ref #3306CA2P02

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS BW Ref #3306BWP02

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • EsFlow PLUS Injectable BW Ref #3306BA2P02

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • PrimaDent Ject+Dental Needles 27G/L (0.4 x 35mm) Ref 6127GL

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • EsFlow PLUS OW Ref #3306OWP04

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Flow A3 Ref Ρ983

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

  • EsFlow PLUS Injectable OW Ref #3306CA2P01

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Flow A2 Ref Ρ982

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

  • Nanohybrid Composite+ A2 Ref 3136571

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ProtoNano A3.5 Ref Ρ995Α35

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Nanofil+ Capsules TW Ref 3136589

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Elegance A1 Ref ML64433

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • PrimaDent Ject+Dental Needles 30G/XS (0.3 x 12mm) Ref 6130XS

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • FineEtch-37 1.2ml Ref #3601P04

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

Rows 1-50 of 318

Showing 1-50 of 318

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000008691
EU VAT number
139-81-34447
EUDAMED status
Active since 2023
EUDAMED registered name
Spident
EUDAMED abbreviated name
Spident
Registered address
109, 117, 203, 304, 307, 312, 314, 315 & 316 Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, 405-821, Incheon, South Korea
PRRC contact
DoKyeong Kim(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 5 Mar 2028

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • C587048 NoMA KOR Active

    Quality management system EU MDR

    Issued
    6 Mar 2023
    Expires
    5 Mar 2028

FDA establishments1

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

  • Spident Co., Ltd. US

Frequently asked questions

How many devices does Spident have in the registry?

The registry currently lists 318 devices for Spident. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spident's devices?

Among its 50 most recently registered devices, Spident has devices listed in EUDAMED (45 devices), FDA 510(k) (5 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Spident's devices fall under?

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

What EUDAMED certificates are recorded for Spident?

EUDAMED lists 1 certificate for Spident (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Mar 2023.

What are the newest devices from Spident in the registry?

The most recently registered devices listed for Spident include OrthoFit Aligner (OrthoFit Aligner A2), EsFlow PLUS BW, EsFlow PLUS OW and supraCXN EsCem A3.

Which FDA establishments are linked to Spident?

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

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