Japan medical device regulatory intelligence, Week 18, 2026.

Signals from 2026-04-27 to 2026-05-03, covering safety alerts, regulatory changes, device registrations, market movement, and source activity for Japan.

Signals
3
Sources
1
Index status
Noindex

This report is visible for continuity, but it is excluded from search indexing until it reaches 5 qualifying signals.

EXECUTIVE SUMMARY

Japan generated 3 qualifying medical device signals during Week 18, 2026. Device registrations led the week with 3 signals, while EUDAMED EU Device Database was the most active source. The Disposable Electrode V-04PO4 by Nihon Kohden is registered as a Class I medical device. The Disposable Electrode V-04PN4 by NIHON KOHDEN is classified as Class I medical device.

Key observations

Device registrations accounted for 3 of 3 qualifying signals, making it the main review lane for the week.
The remaining signals were spread across smaller categories, suggesting a lower-concentration week.
EUDAMED EU Device Database contributed 3 signals, so source-level follow-up should start there.
Disposable appeared repeatedly in the highlighted signals, which may warrant closer product, manufacturer, or competitor tracking.

Category interpretation

Device registrations

3 device registrations appeared in Japan during Week 18, 2026. Registration activity can expose product category momentum, manufacturer movement, and database changes that affect market intelligence.

Recommended monitoring focus

  • Track registration and device database changes for competitor movement and predicate landscape updates.
  • Maintain weekly monitoring for Japan, especially when low-volume weeks precede regulator database updates.
  • Validate high-impact items against the original source before using them in quality or regulatory decision-making.
  • Compare this week with the next completed week to separate one-off noise from sustained category movement.

Source-backed signal evidence

These source-linked items support the weekly analysis above. They are included for verification and follow-up, not as a raw feed export.

EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-04PO4 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

The Disposable Electrode V-04PO4 by Nihon Kohden is registered as a Class I medical device.

Source
EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-04PN4 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

The Disposable Electrode V-04PN4 by NIHON KOHDEN is classified as Class I medical device.

Source
EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-05IN5 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

NIHON KOHDEN CORPORATION's Disposable Electrode V-05IN5 is classified as Class I medical device.

Source

Device registrations

EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-04PO4 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

The Disposable Electrode V-04PO4 by Nihon Kohden is registered as a Class I medical device.

Source
EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-04PN4 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

The Disposable Electrode V-04PN4 by NIHON KOHDEN is classified as Class I medical device.

Source
EUDAMED EU Device Database·Device registrations·

EUDAMED: Disposable Electrode V-05IN5 by NIHON KOHDEN CORPORATION (Class refdata.risk-class.class-i)

NIHON KOHDEN CORPORATION's Disposable Electrode V-05IN5 is classified as Class I medical device.

Source

Track these signals continuously.

MedFlux monitors regulators and medical device market sources across priority countries so regulatory, quality, and strategy teams can review changes without manually checking agency databases.

Related MedFlux intelligence pages