Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005642384

FEI Number

3005642384

Entity Name

Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd

City/State/Country

SHANGHAI, CN

Establishment Address

T6-7 No.5001 Hua Dong Road, Jinqiao South Export Processing Zone, PuDong, SHANGHAI 201201, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Epredia Holdings Ltd. (Owner Number: 10062642)

Owner / Operator Contact Address

20 Post Road, Portsmouth, NH 03801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cryostar-UK NX50 HOPD Cryostar-UK NX70 HOMPV HM525 NX UV Cryostat-UK Cryostar-UK NX70 HOMPDV HM525 NX Cryostat HM525 NX UV Cryostat Cryostar-UK NX50 HOPDV Cryostar-UK NX50 HOP CryoStar NX50 CryoStar NX70 Cryostar-UK NX50 HOPV Cryostar-UK NX70 HOMP HM525 NX Cryostat-UK Gold Seal Epredia Cover Slips HM 340E Rotary Microtome HM 340E Rotary Microtome-UK HM 325 Rotary Microtome HM 355S Rotary Microtome-UK HM 325 Rotary Microtome-UK HM 355S Rotary Microtome HM450 Electronic Sliding Microtome HM430 Manual Sliding Microtome Thermo Scientific - Permafrost Adhesion Microscope Slides Thermo Scientific - Superfrost Cytology Adhesion Microscope Slides Thermo Scientific - Plain Microscope Slides Thermo Scientific - Cel-Line UltraCleanMicroscope Slides ThermoScientific - Polysine Adhesion Microscope Slides ThermoScientific - Cel-Line SuperChip Microscope Slides Thermo Scientific- Superfrost Microscope Slides ThermoScientific - Colormark Microscope Slides Epredia Double Frosted Slides Epredia Petrographic Slides Thermo Scientific - Menzel-Glaser Superfrost PlusMicroscope Slides ThermoScientific - Ink Jet Microscope Slides Epredia Control Slides Thermo Scientific - Cel-Line Adcell Microscope Slides Gold Seal - Frosted CytologyMicroscope Slides Epredia Frozen TissuePlus Slides Thermo Scientific - Frosted Microscope Slides Thermo Scientific - Cel-Line BioGold Microscope Slides Epredia Superfrost Plus GoldSlides Gold Seal - Fluorescent Antibody Microscope Slides Epredia SlideMate Microscope Slides Epredia Colormark Slides ThermoScientific - Permafrost Microscope Slides Gold Seal - Plain Microscope Slides Epredia Colorfrost Slides Thermo Scientific - Colorfrost PLUS Adhesion Microscope Slides Epredia Superfrost Plus Slides Gold Seal - Ultrafrost Frosted Microscope Slides EprediaColormark Plus Slides Thermo Scientific -Excell Adhesion Microscope Slides Thermo Scientific - Cel-Line Poly-L-Lysine Microscope Slides ThermoScientific - Superfrost PLUS Gold Adhesion Microscope Slides 56 Epredia Plain Slides Thermo Scientific - Cel-Line ClearcellMicroscope Slides Thermo Scientific - Ink Jet PLUS Adhesion MicroscopeSlides Thermo Scientific - Menzel-Glaser Microscope Slides Epredia Permafrost Slides Thermo Scientific - Colormark Plus AdhesionMicroscope Slides Thermo Scientific - Premium MicroscopeSlides Gold Seal - Rite-On FrostedMicroscope Slides Epredia Superfrost Slides Epredia Frosted Slides Thermo Scientific - Diagnostic Microscope Slides Thermo Scientific - Menzel-Glaser Superfrost Microscope Slides Epredia Colorfrost Plus Slides Thermo Scientific - Superfrost PLUS Control Adhesion Microscope Slides Epredia Superfrost Excell Slides Epredia PolysineSlides Epredia Ink Jet Slides Epredia Control Plus Slides Thermo Scientific - Superfrost PLUS Adhesion MicroscopeSlides Gold Seal - UltrafrostUltrastick Adhesion Microscope Slides Epredia SlideMateAdhesion Microscope Slides

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2020-03-12
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2020-05-08
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2020-03-12
KFL	Microtome, Sliding	Pathology	Class 1	864.3010	2020-03-12
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2020-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Naveen Krishna Kaki Business: new erie scientific llc Email: naveen.kaki@epredia.com Phone: (857) 2631783

Related Public Records

Same Entity

Epredia Holdings Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011631044	FA-Tech Diagnostics Europe BV	Duiven Gelderland, NL
1219230	NEW ERIE SCIENTIFIC LLC	Portsmouth, NH, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
1831638	RICHARD-ALLAN SCIENTIFIC LLC	KALAMAZOO, MI, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

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1000391282	MILESTONE S.P.A.	Sorisole Bergamo, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005642384. Last updated year: 2026. Please use registration number 3005642384 when referencing this establishment in official correspondence.