Consulting Wallah › Device Explorer › IVD & laboratory › Tissue processor IVD, automated/semi-automated
Device Explorer · FDA GUDID · GMDN 57859

Tissue processor IVD, automated/semi-automated

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological

US‑registered devices108in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Leica Biosystems Nussloch Gmbh3734%
Shandon Diagnostics Limited3633%
Leica Biosystems Melbourne Pty Ltd109%
Abbott Molecular Inc.87%
Sakura Finetek U.S.A., Inc.44%
Dakewe (Shenzhen) Medical Equipment Co., Ltd.33%
Becton, Dickinson And Company33%
Hologic, Inc.22%

Top labelers

CompanyDevicesShare
Leica Biosystems Nussloch Gmbh3734%
Shandon Diagnostics Limited3633%
Leica Biosystems Melbourne Pty Ltd109%
Abbott Molecular Inc.87%
Sakura Finetek U.S.A., Inc.44%
Dakewe (Shenzhen) Medical Equipment Co., Ltd.33%
Becton, Dickinson And Company33%
Hologic, Inc.22%
Biocytech Corporation Sdn. Bhd.22%
Rushabh Instruments, Llc11%
Haho Medi11%
Milestone Srl11%

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

Brand names on the register (sample)

HP-HUGO Automatic Tissue ProcessorHP300Plus Automatic Tissue ProcessorHP300 Automatic Tissue ProcessorEprediaThermo FisherTissue-VIP® 6 AITissue-Tek Xpress®Tissue-Tek VIP® 6Histo-Tek® VP1™HistoCore PEGASUS PlusHistoCore PEGASUSASP6025 S ChinaASP6025 S 120V/50-60HzASP6025 S 230V/50-60HzSilicone PadHistoCore PEARL

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

FDA product codes

CodeNameDevices
IEOProcessor, Tissue, Automated54
IEOPROCESSOR, TISSUE, AUTOMATED40
KEYSTAINER, TISSUE, AUTOMATED8
MKQProcessor, Cervical Cytology Slide, Automated3
IDTAPPARATUS, MELTING POINT, PARAFFIN2
ISAMassager, Therapeutic, Electric1

GMDN & GCC registration

  • GMDN code 57859 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 5% · OTC 35%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Depth (Inch) · 2Width (Inch) · 2Height (Inch) · 2

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

How many tissue processor ivd, automated/semi-automated products are registered in the US?

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tissue processor IVD, automated/semi-automated", from 12 companies. The largest labeler is Leica Biosystems Nussloch Gmbh with 34% of records.

Which FDA product codes apply?

IEO (Processor, Tissue, Automated), IEO (PROCESSOR, TISSUE, AUTOMATED), KEY (STAINER, TISSUE, AUTOMATED), MKQ (Processor, Cervical Cytology Slide, Automated)

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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