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Maruchi

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000030192 FEI 3009560600

Maruchi is a medical device manufacturer based in South Korea, with 16 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa; FDA Class II) as of 13 Nov 2026.

Devices
16
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 12
  • FDA GUDID 6
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class IIa 12
  • FDA Class II 4
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000030192
  • FDA FEI 3009560600
  • DUNS 557821685

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 FEI
Authorised rep.
KTR Europe GmbHDE

What Maruchi makes

Maruchi makes dental products, including dental coatings for tooth desensitization and hygroscopic dental cements. Examples of their products include AH Plus Bioceramic Sealer and various ENDOCEM and ENDOSEAL MTA products.

The company's portfolio is regulated under Class II and Class IIa devices and is listed in registries such as Eudamed and the FDA's 510k and UDI databases. Maruchi is based in South Korea.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices
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  • AH Plus Bioceramic Sealer Starter Kit

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

  • Endocem Mta

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

  • Endocem Zr Ref K133042

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

  • Endocem Mta (Mineral Trioxide Aggregate) Ref K112078

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

  • ENDOSEAL MTA(3 g) Ref 04299

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOSEAL MTA(2 g) Ref 04329

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOCEM PREMIXED REGULAR(3 g) Ref 00130

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOSEAL MTA(3 g) Ref 04305

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOCEM MTA PREMIXED LIGHT(2 g) Ref 01335

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOSEAL MTA(3 g) Ref 00000

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • White ENDOSEAL MTA(3 g) Ref 00093

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • White ENDOSEAL MTA(2 g) Ref 00321

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • ENDOCEM MTA PREMIXED LIGHT(3 g) Ref 00123

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ENDOSEAL MTA(2 g) Ref 04312

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • CleaniCal Ref 00017

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • ENDOCEM PREMIXED REGULAR(2 g) Ref 00291

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

Rows 1-16 of 16

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000030192
FDA FEI number
3009560600
DUNS number
557821685
EUDAMED status
Active
EUDAMED registered name
MARUCHI
EUDAMED abbreviated name
MARUCHI
Registered address
101, Donghwagongdan-ro, 26365, Wonju-si, South Korea
PRRC contact
Hye-Eun Lee(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 17 Jul 2030

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2025873-1 Active

    Quality management system EU MDR

    Issued
    18 Jul 2025
    Expires
    17 Jul 2030

Frequently asked questions

How many devices does MARUCHI have in the registry?

The registry currently lists 16 devices for MARUCHI. Devices recorded under merged duplicate company entries are counted once.

Which registries list MARUCHI's devices?

Among its 16 most recently registered devices, MARUCHI has devices listed in EUDAMED (12 devices), FDA 510(k) (2 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MARUCHI's devices fall under?

Among its 16 most recently registered devices, the classes recorded for MARUCHI's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for MARUCHI?

EUDAMED lists 1 certificate for MARUCHI (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 18 Jul 2025.

What are the newest devices from MARUCHI in the registry?

The most recently registered devices listed for MARUCHI include AH Plus Bioceramic Sealer Starter Kit, ENDOCEM MTA, ENDOCEM ZR and ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE).

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