Manufacturer

Shandon Diagnostics

United Kingdom (ex Northern Ireland)Legal entities : Shandon Diagnostics Limited

Markets : Netherlands · UK · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 1 · class II · latest in 2025 · see on the FDA website

Public contracts won : UK 1

EU representative : Epredia Netherlands B.V. (Netherlands)

12 categories, 24 models including 24 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Microtomes	W0202059005	Cool-Cut HM 355S Rotary Microtome3 refs HM 325 HM325 Rotary Microtome3 refs HM 430 Sliding Microtome2 refs HM 450 Sliding Microtome HM340E Rotary Microtome3 refs	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	12ml VIAL WITH CAP KIT3 refs BASKET AND CARRIER3 refs EVAPORATION COVER3 refs PT Module	A IVDR	EUDAMED record Report an error
Cryostat microtomes	W0202059003	Cryostar NX50 HOP HC Cryostar NX50 Cryostat3 refs Cryostar NX70 HOMP Cryostar NX70 Cryostat3 refs HM525 NX HC HM525 NX Cryostat3 refs	A IVDR	EUDAMED record Report an error
Tissue processors	W0202059010	5 Litre Reagent bottle - Empty (set of 6 bottles)3 refs BASKET DIVIDER ASSY3 refs PARAFIN BATH STP120 Tissue Processor3 refs	A IVDR	EUDAMED record Report an error
Automated coverslippers	W0202059008	ADAPTER F JUNG CTM6 Coverslipper3 refs BASKET STAND COMPLETE A792000013 refs	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Manual Unloaded Screwdriver3 refs	A IVDR	EUDAMED record Report an error
Biopsy cartridges	W05020106	Bionet Cassettes - Aqua3 refs	A IVDR	EUDAMED record Report an error
Centrifuges	W02069003	Cytospin 4 Cytocentrifuge3 refs	A IVDR	EUDAMED record Report an error
Cervical screening systems	W02020502	Shandon™ PapSpin™	A IVDR	EUDAMED record Report an error
Digital laboratory microscopes	W0202050304	Epredia E1000 Dx Digital Pathology Solution	A IVDR	EUDAMED record Report an error
Embedding media (histology/cytology)	W01030704	Histoplast 10kg2 refs	A IVDR	EUDAMED record Report an error
Tissue embedding processors	W0202059004	CABLE A810000043 refs	A IVDR	EUDAMED record Report an error

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