Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011631044

FEI Number

3011631044

Entity Name

FA-Tech Diagnostics Europe BV

City/State/Country

Duiven Gelderland, NL

Establishment Address

't Holland 31, Duiven Gelderland 6921 GX, NL

Establishment Type(s)

Manufacture Medical Device,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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2020-02-28

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
1219230	NEW ERIE SCIENTIFIC LLC	Portsmouth, NH, US
3005642384	Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd	SHANGHAI, CN
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
1831638	RICHARD-ALLAN SCIENTIFIC LLC	KALAMAZOO, MI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011631044. Last updated year: 2026. Please use registration number 3011631044 when referencing this establishment in official correspondence.