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Zmi Elecronics, Ltd.

Active in EUDAMED

Registered as ZMI Electronics Ltd. (ZMI) in EUDAMED

Also registered as ZMI Electronics Ltd.

Taiwanfrom SRN EUDAMED FDA SRN TW-MF-000003571 FEI 1000442645

Zmi Elecronics, Ltd. is a medical device manufacturer based in Taiwan, with 135 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I; FDA Class II) as of 14 Nov 2026.

Devices
135
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 103
  • FDA GUDID 28
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • EU Class I 103
  • FDA Class II 32
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN TW-MF-000003571
  • FDA FEI 1000442645

At a glance

Counted by deviCERTS from registry records

Market reach

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

What Zmi Elecronics, Ltd. makes

Zmi Electronics, Ltd. manufactures wireless transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices, including models such as Bruno and Aela.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue135

Newest first, rows 1-50 of 135

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  • Levina PFR-01-NS

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

  • Levina PFR-03-NS

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

  • Levina PFR-02-NS

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

  • Levina RS-48

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

  • NeuroMD RS-18

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

  • PowerDot SAE-MC-PD-01MTBL

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

  • Levina SAE-MPBFPK2

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

  • Levina SAE-MPBFPK1

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

  • PowerDot PD-01R

    Listed Registry: GUDID Class:II

  • Levina SAE-MPBFBL1

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

  • CareWear ® CWC-1

    Listed Registry: GUDID Class:II

  • Mettler ME4000

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

  • Zmi Sae-Mc-R-Pd

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

  • PowerDot PD-01MR

    Listed Registry: GUDID Class:II

  • PowerDot SAE-MC-B-200BFLP

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

  • PowerDot PD-01MB

    Listed Registry: GUDID Class:II

  • Zmi Sae-Mc-B-Pd

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

  • Levina SAE-MPBFBL2

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

  • Levina SAE-MPBFPK

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

  • PowerDot SAE-MC-USA-PD

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

  • PowerDot PD-01W

    Listed Registry: GUDID Class:II

  • Levina RS-18

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

  • Zmi Sae-Mc-R-Pd

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

  • Zmi Sae-Mc-B-Pd

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

  • PowerDot PD-01B

    Listed Registry: GUDID Class:II

  • Levina SAE-MPBFBL

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

  • Levina RS-38

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

  • PowerDot PD-01MT

    Listed Registry: GUDID Class:II

  • Gymna-Uniphy Ref MLT23700-GU

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rubber Electrode Ref LP34-502-24F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Zimmer Group Ref SPS-D-1460266

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Vacuum Electrode Lead Ref VEL-574S

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Physiomed Ref SPS-D-150200-PH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Zimmer Group Ref VEC-062P-ZMR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Electrode Sponge Ref SPS-P-090105

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Zimmer Group Ref VEL-564S-ZMR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rubber Electrode Ref LP812-502-24F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Gymna-Uniphy Ref LP68-340468

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rubber Electrode Ref LP34-502-44F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Physiomed Ref SPS-R-20090-PH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Gymna-Uniphy Ref LP68B-152-22F-GU

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Zimmer Group Ref LP46-502-22FP-ZMR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Rubber Electrode Ref PRU-050050

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Gymna-Uniphy Ref SPS-R-11065P-GU

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Gymna-Uniphy Ref LP812B-152-22F-GU

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Electrode Sponge Ref SPS-R-11065

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes Ref K231166

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

  • ZMI Self-Adhesive Electrodes Ref K180865

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

  • Wireless TENS/EMS, Bruno, Aela Ref K220997

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

  • Levina Pelvic Floor Muscle Stimulator (RS-48) Ref K241862

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

Rows 1-50 of 135

Showing 1-50 of 135

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
TW-MF-000003571
FDA FEI number
1000442645
EUDAMED status
Active
EUDAMED registered name
ZMI Electronics Ltd.
EUDAMED abbreviated name
ZMI
Registered address
No. 286-4, 6F-1, Shin Ya Road, 806, Kaohsiung, Taiwan
Phone
+886-7-8150053
PRRC contact
Lawrence Liu(public in EUDAMED)

Frequently asked questions

How many devices does Zmi Elecronics, Ltd. have in the registry?

The registry currently lists 135 devices for Zmi Elecronics, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Zmi Elecronics, Ltd.'s devices?

Among its 50 most recently registered devices, Zmi Elecronics, Ltd. has devices listed in EUDAMED (18 devices), FDA 510(k) (4 devices) and FDA GUDID (28 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Zmi Elecronics, Ltd.'s devices fall under?

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

What are the newest devices from Zmi Elecronics, Ltd. in the registry?

The most recently registered devices listed for Zmi Elecronics, Ltd. include Levina PFR-01-NS, Levina PFR-03-NS, Levina PFR-02-NS and Levina RS-48.

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