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Zeros Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000020402 FEI 3032439351

Devices
2,481
Registrations
EUDAMEDFDA
FDA recalls
0

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

What Zeros Co., Ltd. makes

Zeros Co., Ltd. manufactures the STERI-OSS Implant System, a medical device designed for orthopedic applications, likely intended for bone fixation or regeneration in surgical procedures.

The STERI-OSS Implant System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2,481

Newest first, rows 1-50 of 2,481

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Rows 1-50 of 2,481

Showing 1-50 of 2,481

Company details

EUDAMED SRN
KR-MF-000020402
FDA FEI number
3032439351
EU VAT number
6098613820
EUDAMED status
Active
EUDAMED registered name
ZEROS Co., Ltd.
Registered address
Building A, 27, Seogimhaesandanan-gil, 50967, Gimhae-si, Gyeongsangnam-do, South Korea
PRRC contact
UK-HYON JOO(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 17 May 2031

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2166677-1 Issued

    Quality management system EU MDR

    Issued
    18 May 2026
    Expires
    17 May 2031

Frequently asked questions

How many devices does Zeros Co., Ltd. have in the registry?

The registry currently lists 2481 devices for Zeros Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zeros Co., Ltd.'s devices?

Among its 50 most recently registered devices, Zeros Co., Ltd. has devices listed in EUDAMED (50 devices).

What risk classes do Zeros Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Zeros Co., Ltd.'s devices are Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Zeros Co., Ltd.?

EUDAMED lists 1 certificate for Zeros Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-05-18.

What are the newest devices from Zeros Co., Ltd. in the registry?

The most recently registered devices listed for Zeros Co., Ltd. include ZEROS Dental Implant System.

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