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Halo Sterile Single-use Radial Fiber

by Micro-Energy Medical Technology Co., Ltd. 2 variants

Ref Halo-R-0.60-2.5

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697671297fiber00025 Basic UDI-DI 06976712970044UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06976712970044 UDI-DI Date20 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
General/multiple surgical laser system beam guide, single-use
Device Name
Sterile Single-use Radial Fiber
Model / Reference
Halo-R-0.60-2.5
Primary DI / UDI-DI
06976712970044 EUDAMED
06976712970259 GUDID
Basic UDI-DI
697671297fiber00025
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011085 Laser surgery instruments - consumables
GMDN Term
General/multiple surgical laser system beam guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06976712970044
GUDID
06976712970259
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000050470
Authorised representative
MedPath GmbH DE-AR-000000087

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 (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No