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Globalipl

by Beijing Globalipl Development Co., Ltd 2 variants

Ref US800

Globalipl (US800) is a dermatological carbon dioxide laser system (EU MDR Class IIb; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Beijing Globalipl Development Co., Ltd., registered in EUDAMED on 4 Nov 2024 (Basic UDI-DI B-06973494938026) and listed in FDA GUDID since 16 Aug 2022 (UDI-DI 06973494938026), active as of 22 Oct 2026.

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

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-06973494938026 Basic UDI-DI 06973494938026UDI-DIDate4 Nov 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06973494938026 Basic UDI-DI 06973494938026UDI-DIDate4 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06973494938026 UDI-DI Date16 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06973494938026 registered 4 Nov 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 06973494938026 listed 16 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06973494938026
  2. Registered EUDAMED B-06973494938026

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Globalipl EUDAMEDGUDID
CO2 Fractional Laser Equipment EUDAMED
Generic name
Dermatological carbon dioxide laser system
Model / reference
US800
Primary DI / UDI-DI
06973494938026 EUDAMED
06973494938002 GUDID
Basic UDI-DI
B-06973494938026, 697349493CO2US
Direct marketing DI
06973494938026
FDA product code
GEX
EMDN code
Z12011005 Carbon dioxide surgical laser
GMDN term
Dermatological carbon dioxide laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06973494938026
GUDID
06973494938002
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06973494938026; FDA GUDID lists 06973494938002), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000010924
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under CARBON DIOXIDE SURGICAL LASER.

Other devices from Beijing Globalipl Development Co., Ltd.

See all devices from Beijing Globalipl Development Co., Ltd. →

Properties

  • Sterilise before use NoEUDAMEDGUDIDYesEUDAMED
  • Reusable YesEUDAMEDNoEUDAMED
  • Serial number
  • Expiration date
Other properties (21, all answered No)