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Hemolase Fiber Hemo-R-0.60-1.8

by Micro-Energy Medical Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number06976712970327 UDI-DI Date13 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hemolase Fiber
Generic Name
General/multiple surgical laser system beam guide, single-use
Model / Reference
Hemo-R-0.60-1.8
Primary DI / UDI-DI
06976712970327
510(k) Number
FDA Product Code
GEX
GMDN Term
General/multiple surgical laser system beam guide, single-use
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261701)

Other devices from Micro-Energy Medical Technology Co., Ltd.

See all devices from Micro-Energy Medical Technology Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No