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TOP-100Plus

by Alltion (Guangxi) Instrument Co., Ltd.

Ref many

TOP-100Plus (many) is a general-purpose surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Alltion (Guangxi) Instrument Co., Ltd., registered in EUDAMED on 21 Apr 2026 (Basic UDI-DI 697044351TOP100JC) and listed in FDA GUDID since 9 Sep 2026 (UDI-DI 06970443510630), active as of 22 Oct 2026.

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

CE MDR

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
United StatesGUDID listing GUDID Number06970443510630 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697044351TOP100JC Basic UDI-DI 06970443510630UDI-DIDate21 Apr 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697044351TOP100JC registered 21 Apr 2026 Active
  • FDA GUDID UDI-DI 06970443510630 listed 9 Sep 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697044351TOP100JC
  2. Listed FDA GUDID 06970443510630

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  • Withdrawn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
TOP-100Plus EUDAMED
Alltion GUDID
Generic name
General-purpose surgical microscope
Model / reference
many EUDAMED
TOP-100Plus GUDID
Primary DI / UDI-DI
06970443510630
Basic UDI-DI
697044351TOP100JC
Direct marketing DI
06970443510630
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
General-purpose surgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
many
GUDID
TOP-100Plus

Manufacturer details

EUDAMED SRN
CN-MF-000024670
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

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See all devices from Alltion (Guangxi) Instrument Co., Ltd. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)