FDA Registration
Active
🇬🇧 United Kingdom
SHANDON DIAGNOSTICS LIMITED
Reg #: 3003584784
·
FEI: 3003584784
·
Expires 2026
Products
15
Proprietary Names
218
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- SHANDON DIAGNOSTICS LIMITED
- Registration Number
- 3003584784
- FEI Number
- 3003584784
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- TUDOR ROAD, MANOR PARK
- City
- RUNCORN Cheshire East
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K241717
Owner / Operator
- Firm Name
- Epredia Holdings Ltd.
- Operator Number
- 10062642
- Address
- 20 Post Road
- City
- Portsmouth
- State
- NH
- Postal Code
- 03801
- Country
- US
US Agent
- Business Name
- new erie scientific llc
- Contact Name
- Naveen Kaki
- Address
- 20 post rd
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 857 2631783
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2020-03-12 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2020-02-28 |
| Digital Pathology Display | PZZ | Class 2 | Pathology | No | 2025-03-02 |
| Whole Slide Imaging System | PSY | Class 2 | Pathology | No | 2025-03-02 |
| Digital Pathology Image Viewing And Management Software | QKQ | Class 2 | Pathology | No | 2025-03-02 |
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2020-03-12 |
| Microtome, Sliding | KFL | Class 1 | Pathology | No | 2020-03-12 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2020-03-12 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2020-03-12 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2020-03-12 |
| Slide Stainer, Immersion Type | KIO | Class 1 | Pathology | No | 2020-03-12 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2020-03-12 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2020-03-12 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2020-03-12 |
| Device For Sealing Microsections | KIM | Class 1 | Pathology | No | 2020-03-12 |
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
Epredia Cytospin 4
Gemini AS
Autostainer 480S
Linistat
Autostainer 360
PT Module
Autostainer 720
SlideBasket Transfer System
CTM6 Automated Glass CoverSlipper
ClearVue
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198