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SurgiLight 1470 Diode Laser System Halo

by Micro-Energy Medical Technology Co., Ltd.

Ref Halo

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 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697671297Laser000Q8 Basic UDI-DI 06976712970051UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06976712970051 UDI-DI Date17 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 25 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  • Withdrawn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

Trade Name
SurgiLight 1470 Diode Laser System
Generic Name
General/multiple surgical diode laser system
Device Name
Diode Laser System
Model / Reference
Halo
Primary DI / UDI-DI
06976712970051 EUDAMED
06976712970235 GUDID
Basic UDI-DI
697671297Laser000Q8
Direct Marketing DI
06976712970051
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011016 Diode surgical laser
GMDN Term
General/multiple surgical diode laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06976712970051
GUDID
06976712970235
Device ClassEUDAMED
Class IIb
GUDID
Class II

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

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Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

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