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Eclipse Mini

by Spacelabs Healthcare (Washington), Inc 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841522131639 UDI-DI Date29 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0685-2025 FDA Class II initiated 25 Nov 2024

    Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Electrocardiographic ambulatory recorder
Model / Ref / Catalog
Eclipse Mini, 98900-UK
Primary DI / UDI-DI
10841522131639
510(k) Number
FDA Product Code
MWJ
GMDN Term
Electrocardiographic ambulatory recorder
Device Class
Class II
Regulation Number
870.2800
GUDID distribution status
In Commercial Distribution

Other devices from Spacelabs Healthcare (Washington), Inc

See all devices from Spacelabs Healthcare (Washington), Inc →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No