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Device Explorer · FDA GUDID · GMDN 61826

Microscope slide coverslipper IVD

An automated mains electricity (AC-powered) laboratory instrument intended to be used to apply a coverslip over a microscope examination slide to protect the fixed/stained specimen from mechanical forces or environmental exposure prior to microscopic examinati

US‑registered devices50in commercial distribution
Companies4labelers on GUDID
Single‑use8%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Shandon Diagnostics Limited4182%
Ningbo Chiwell Biotechnology Co., Ltd48%
Sakura Finetek U.S.A., Inc.48%
Dakewe (Shenzhen) Medical Equipment Co., Ltd.12%

Top labelers

CompanyDevicesShare
Shandon Diagnostics Limited4182%
Ningbo Chiwell Biotechnology Co., Ltd48%
Sakura Finetek U.S.A., Inc.48%
Dakewe (Shenzhen) Medical Equipment Co., Ltd.12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Chiwell BiotechnologyCS500 Glass CoverslipperEprediaThermo FisherTissue-Tek® Glas™ g2Tissue-Tek Film®Tissue-Tek Prisma®

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KIMDevice For Sealing Microsections42
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 4
KIMDEVICE FOR SEALING MICROSECTIONS3
KIOSLIDE STAINER, IMMERSION TYPE1

GMDN & GCC registration

  • GMDN code 61826 · non‑implantable
  • Single‑use 8% · sterile 0% · Rx‑only 0% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many microscope slide coverslipper ivd products are registered in the US?

50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microscope slide coverslipper IVD", from 4 companies. The largest labeler is Shandon Diagnostics Limited with 82% of records.

Which FDA product codes apply?

KIM (Device For Sealing Microsections), LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted ), KIM (DEVICE FOR SEALING MICROSECTIONS), KIO (SLIDE STAINER, IMMERSION TYPE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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