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Hakko Co., Ltd.

Active in EUDAMED

Japanfrom SRN EUDAMED FDA SRN JP-MF-000010711 FEI 3002807220

Hakko Co., Ltd. is a medical device manufacturer based in Japan, with 172 devices listed in FDA GUDID and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
172
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 166
  • EUDAMED 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 166
  • EU Class IIa 6
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN JP-MF-000010711
  • FDA FEI 3002807220
  • DUNS 693273427

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
MDSS GmbHDE

Catalogue172

Newest first, rows 1-50 of 172

Search and filter all 172 devices
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  • Sonopsy C1_21G×170 ㎜ Ref SPC12117

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sonopsy C1_18G×170 ㎜ Ref SPC11817

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lap Protector - FF0707L

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Lap Protector - FF1010H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Curved Tip Needle SBB89-22

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

  • Nerve Block Needle SB152-22

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

  • EchoTuohy Epidural Needle E6-2150-17

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

  • Spinal Needle XN203-25

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

  • PTC Spinal Needle 4PTC18

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

  • Nerve Block Needle SB152-25

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

  • EchoBlock EB-2150

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

  • EchoStim ES-20150

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

  • Tuohy Epidural Needle 2-2150-18

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

  • Tuohy Epidural Needle 6-2150-20

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

  • Tuohy Epidural Needle 3-2150-20

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

  • Spinal Needle 8-1149-22

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

  • EchoStim ES-2180

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

  • Spinal Needle 6-1149-25

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

  • Spinal Needle 8-1149-20

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

  • EchoTuohy Epidural Needle E3-2150-18

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

  • Chiba-Type Spinal Needle 8PTC3020

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

  • Tuohy Epidural Needle 4-2150-22

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

  • Spinal Needle 8-1149-18

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

  • Tuohy Epidural Needle 4-2150-18

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

  • Spinal Needle 5-1149-25

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

  • PTC Spinal Needle 2PTC18

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

  • PTC Spinal Needle 6PTC22

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

  • Tuohy Epidural Needle 6-2150-18

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

  • Spinal Needle XN120-22

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

  • Tuohy Epidural Needle 6-2150-17

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

  • Tuohy Epidural Needle 5-2150-18

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

  • Spinal Needle XN152-22

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

  • PTC Spinal Needle 6PTC25

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

  • Curved Tip Needle SBB63-25

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

  • Sonopsy-C1 SON21100

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

  • Tuohy Epidural Needle 3-2150-17

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

  • Curved Tip Needle SBB89-25

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

  • Spinal Needle P1B-1149-25

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

  • Spinal Needle P1B-1149-22

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

  • Spinal Needle XN254-22

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

  • PTC Spinal Needle 3PTC22

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

  • PTC Spinal Needle 5PTC22

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

  • Tuohy Epidural Needle 3-2150-22

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

  • Tuohy Epidural Needle 8-2150-17

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

  • EchoBlock EB-2180

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

  • Spinal Needle P1A-1149-22

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

  • Tuohy Epidural Needle 40-2150-17

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

  • EchoStim ES-21150

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

  • Chiba-Type Spinal Needle 5PTC3022

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

  • EchoBlock MSK EBA-22100

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

Rows 1-50 of 172

Showing 1-50 of 172

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
JP-MF-000010711
FDA FEI number
3002807220
DUNS number
693273427
EUDAMED status
Active
EUDAMED registered name
HAKKO CO., LTD.
Registered address
1490 O-aza Isobe, 389-0806, Chikuma-Shi, Nagano, Japan
Phone
513-271-2117
PRRC contact
Hiroshi Sato(public in EUDAMED)

Frequently asked questions

How many devices does HAKKO CO., LTD. have in the registry?

The registry currently lists 172 devices for HAKKO CO., LTD.. Devices recorded under merged duplicate company entries are counted once.

Which registries list HAKKO CO., LTD.'s devices?

Among its 50 most recently registered devices, HAKKO CO., LTD. has devices listed in EUDAMED (4 devices) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do HAKKO CO., LTD.'s devices fall under?

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

What are the newest devices from HAKKO CO., LTD. in the registry?

The most recently registered devices listed for HAKKO CO., LTD. include SONOPSY C1_21G×170 ㎜, SONOPSY C1_18G×170 ㎜, LAP PROTECTOR - FF0707L and LAP PROTECTOR - FF1010H.

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