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Med-Tech Inc.

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000016597

Med-Tech Inc. is a medical device manufacturer based in Japan, with 2 devices listed in EUDAMED (EU Class IIb) as of 13 Nov 2026.

Devices
2
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 2
Device classes
  • EU Class IIb 2
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN JP-MF-000016597

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.
Asahi Kasei Medical Europe GmbHDE

Catalogue2

Newest first, rows 1-2 of 2

  • PlasautoΣ-CP Ref No.2023.6-G-0771

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • PlasautoΣ Ref No.2023.6-G-0771

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
JP-MF-000016597
EUDAMED status
Active
EUDAMED registered name
MED-TECH INC.
Registered address
1-103-66, Yoshinodai, Kawagoe-Shi, 3500833, Saitama, Japan
PRRC contact
Tadashi Fukasawa(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 4 Jun 2031

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 778677 Active

    Quality management system EU MDR

    Issued
    5 Jun 2026
    Expires
    4 Jun 2031

FDA establishments1

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

  • Medtech LLC Millington, TN · US FEI 3010123256

Frequently asked questions

How many devices does MED-TECH INC. have in the registry?

The registry currently lists 2 devices for MED-TECH INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MED-TECH INC.'s devices?

Among its 2 most recently registered devices, MED-TECH INC. has devices listed in EUDAMED (2 devices).

What risk classes do MED-TECH INC.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for MED-TECH INC.'s devices are Class IIb. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for MED-TECH INC.?

EUDAMED lists 1 certificate for MED-TECH INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 5 Jun 2026.

What are the newest devices from MED-TECH INC. in the registry?

The most recently registered devices listed for MED-TECH INC. include PlasautoΣ-CP and PlasautoΣ.

Which FDA establishments are linked to MED-TECH INC.?

1 FDA establishment is linked to MED-TECH INC. in the registry; they are listed on the company page.

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