Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003584784

FEI Number

3003584784

Entity Name

SHANDON DIAGNOSTICS LIMITED

City/State/Country

RUNCORN Cheshire East, GB

Establishment Address

TUDOR ROAD, MANOR PARK, RUNCORN Cheshire East WA7 1TA, GB

Establishment Type(s)

Manufacture Medical Device

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

Digital Baths, GeneralPurpose (TSGP10) ISOTemp Baths, General Purpose (FSSWB27) Incubators, General Purpose (3948) Forma Incubators, General Purpose (3403) FormaIncubators, General Purpose (3950) Forma Incubators, General Purpose (3310) Digital Baths, General Purpose(TSGP2S) ISOTemp Baths, General Purpose (FSGPD2S) Forma Incubators, General Purpose (3010) Digital Baths,General Purpose (TSGP02) Digital Baths, General Purpose (TSGP28) FormaIncubators, General Purpose (3960) Forma Incubators, General Purpose (3977) Forma Incubators, General Purpose (3308) ISOTemp Incubators,General Purpose (FB3533DH) ISOTemp Incubators, General Purpose(FB3531WJ) Forma Cell Rollers (4868) Shaking Baths,General Purpose (TSSWB27) Forma Incubators, General Purpose (3425) Digital Baths, General Purpose (TSGP05) Forma Gas Guard (3050) ISOTemp Baths, General Purpose(FSGPD05) Forma Incubators, General Purpose (380) ISOTemp Incubators, General Purpose (FB3532DH) FormaIncubators, General Purpose (3913) Forma HI-TMP BATH 160A 11-481 -A- (88151Q) ISOTemp Baths,General Purpose (FSSWB15) ISOTemp Baths, GeneralPurpose (FSGPD28) Circulating Baths,General Purpose (TSCIR35) Incubators,General Purpose (3907) Forma Incubators, General Purpose (3307) Shaking Baths,General Purpose (TSSWB15) ISOTemp Baths, General Purpose (FSGPD10) Digital Baths, GeneralPurpose (TSGP20) Forma Incubators, General Purpose (3429) Forma Incubators, General Purpose (3542) ISOTemp Baths, General Purpose (FSGPD02) Coliform Baths, General Purpose (TSCOL35) Circulating Baths, General Purpose (TSCIR19) FormaIncubators, General Purpose (3940) Forma Incubators, General Purpose (3951) ISOTemp Baths, General Purpose(FSGPD15D) Forma Incubators, General Purpose (3063) Forma Incubators, General Purpose (3424) ISOTemp Baths, General Purpose (FSGPD20) Forma Incubators, General Purpose (3961) Forma Incubators, General Purpose (3540) Forma Cell Rollers (4862) FormaIncubators, General Purpose (371) Forma Incubators, General Purpose (3422) Forma Incubators, General Purpose (3949) Forma Incubators, General Purpose (3311) Forma Incubators, General Purpose (370) Circulating Baths, General Purpose (TSCIR89) Forma Incubators, General Purpose (3426) Incubators, General Purpose(3962) Shaking Baths, General Purpose (TSSWB15S) Forma Incubators, General Purpose (3920) FormaIncubators, General Purpose (3975) Forma Incubators, General Purpose (3020) Forma Incubators, General Purpose (3405) Forma Incubators, General Purpose (3427) ISOTempIncubators, General Purpose (FB3530WJ) Digital Baths, General Purpose (TSGP15D) Forma Incubators, General Purpose (3911) Forma Incubators, General Purpose (3057) Forma Incubators, General Purpose (3543) Forma Incubators, General Purpose (3428) FormaIncubators, General Purpose (381) Forma Incubators, General Purpose (3423) Shaking Baths, General Purpose (TSDUB15) Forma Incubators, General Purpose (3541) Coliform Baths,General Purpose (TSCOL19) Laser biopsy cassettes in stripped stacks (aqua) 25x40 with hinged lid Bionet cassettes in stripped stacks (ochre) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (green) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (ochre) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (yellow) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (white) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (ochre) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (beige) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 45x40 without lid (require metal lid) Epredia PrintMate Slotted Cassette Epredia Tissue Cassette I Epredia Embedding Rings Epredia PrintMate Biopsy Cassette Epredia Tissue Capsule pads Epredia Cassette 2 Slotted Laser biopsy cassettes in stripped stacks (red) 25x40 with front lid Laser biopsy cassettes in stripped stacks (ochre) 25x40 with front lid Epredia Cassette II Tissue Laser biopsy cassettes in stripped stacks (red) 25x40 with hinged lid Bionet cassettes in stripped stacks (beige) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (lilac) 45x40 without lid (require metal lid) Bionet cassettes in stripped stacks (blue) 25x40 with front lid Tissue Cassette Embedded Lid Laser embedding cassettes in stripped stacks (aqua) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (blue) 25x40 with front lid Epredia Embedding Cassettes without Lids Laser embedding cassettes in stripped stacks (grey) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (orange) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (white) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 25x40 with front lid Laser embedding cassettes in stripped stacks (yellow) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (pink) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (yellow) 45x40 with integrated lid Epredia Thinline Slotted Cassette Laser biopsy cassettes in stripped stacks (aqua) 25x40 with front lid Laser biopsy cassettes in stripped stacks (yellow) 25x40 with front lid Laser embedding cassettes in stripped stacks (ochre) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 25x40 with front lid Laser embedding cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (orange) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (green) 25x40 with front lid Laser embedding cassettes in stripped stacks (blue) 45x40 with integrated lid Epredia Fine Pore Cassette Laser biopsy cassettes in stripped stacks (yellow) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (green) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (blue) 25x40 with hinged lid Bionet cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (grey) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (grey) 45x40 with integrated lid Bionet cassettes in stripped stacks (white) 25x40 with front lid Bionet cassettes in stripped stacks (green) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 45x40 with integrated lid Epredia Biopsy Cassette I Laser biopsy cassettes in stripped stacks (orange) 25x40 with front lid Laser biopsy cassettes in stripped stacks (grey) 25x40 with front lid Laser biopsy cassettes in stripped stacks (white) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (white) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (lilac) 25x40 with hinged lid Bionet cassettes in stripped stacks (orange) 25x40 with front lid Fa-Tech Biopsy Cassettes Laser embedding cassettes in stripped stacks (white) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (lilac) 45x40 with integrated lid Bionet cassettes in stripped stacks (aqua) 25x40 with front lid Laser embedding cassettes in stripped stacks (red) 25x40 with hinged lid Bionet cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (beige) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (beige) 25x40 with front lid Bionet cassettes in stripped stacks (grey) 25x40 with front lid Bionet cassettes in stripped stacks (yellow) 25x40 with front lid Laser embedding cassettes in stripped stacks (yellow) 25x40 with front lid Laser biopsy cassettes in stripped stacks (white) 25x40 with front lid Laser embedding cassettes in stripped stacks (orange) 45x40 with integrated lid Fa-Tech Embedding Cassettes Laser biopsy cassettes in stripped stacks (blue) 25x40 with hinged lid Epredia HistoScreen Cassette Laser embedding cassettes in stripped stacks (red) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (lilac) 25x40 with hinged lid Epredia Metal Lids Epredia PrintMate Embedding Cassette Laser embedding cassettes in stripped stacks (orange) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (beige) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (beige) 25x40 with front lid Laser embedding cassettes in stripped stacks (aqua) 45x40 with integrated lid Laser embedding cassettes in stripped stacks (blue) 45x40 without lid (require metal lid) Bionet cassettes in stripped stacks (red) 25x40 with front lid Laser embedding cassettes in stripped stacks (blue) 25x40 with front lid Epredia TissueLoc Slotted Cassette Laser embedding cassettes in stripped stacks (beige) 45x40 with integrated lid Laser biopsy cassettes in stripped stacks (pink) 25x40 with front lid Laser embedding cassettes in stripped stacks (ochre) 45x40 without lid (require metal lid) Laser embedding cassettes in stripped stacks (orange) 25x40 with front lid Laser embedding cassettes in stripped stacks (grey) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (pink) 45x40 without lid (require metal lid) Laser biopsy cassettes in stripped stacks (grey) 25x40 with hinged lid Laser biopsy cassettes in stripped stacks (green) 25x40 with front lid Laser biopsy cassettes in stripped stacks (lilac) 25x40 with front lid Laser embedding cassettes in stripped stacks (pink) 25x40 with hinged lid Laser embedding cassettes in stripped stacks (ochre) 25x40 with hinged lid Epredia E1000 Dx Digital Pathology Solution Flotation Tissue Bath HM450 Electronic Sliding Microtome HM430 Manual Sliding Microtome 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 Revos STP 120 Excelsior AS 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 Immersion Slide Stainer HistoStar Cold Mod 100-120V HistoStar System240V HistoStarEmbedding Mod HistoStar System 220-240V HistoStar Cold Mod 220-240V HistoStar System 100-120V

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2020-03-12
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2020-02-28
PZZ	Digital Pathology Display	Pathology	Class 2	864.3700	2025-03-02
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2025-03-02
QKQ	Digital Pathology Image Viewing And Management Software	Pathology	Class 2	864.3700	2025-03-02
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2020-03-12
KFL	Microtome, Sliding	Pathology	Class 1	864.3010	2020-03-12
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2020-03-12
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2020-03-12
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2020-03-12
KIO	Slide Stainer, Immersion Type	Pathology	Class 1	864.3800	2020-03-12
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2020-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Naveen 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
3005642384	Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd	SHANGHAI, CN
1831638	RICHARD-ALLAN SCIENTIFIC LLC	KALAMAZOO, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003584784. Last updated year: 2026. Please use registration number 3003584784 when referencing this establishment in official correspondence.