Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005787343

FEI Number

3005787343

Entity Name

CELLPATH LTD

City/State/Country

NEWTOWN Powys, GB

Establishment Address

80 MOCHDRE ENTERPRISE PARK, NEWTOWN Powys SY16 4LE, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CELLPATH LTD (Owner Number: 8021890)

Owner / Operator Contact Address

80 MOCHDRE ENTERPRISE PARK, NEWTOWN, GB-POW SY16 4LE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ClariTex Microscope Slides HistoBond+ MicroScope Slides CellTec Wax Dispenser CellEdge Microtome Blades Supa Mega Cassette Clamp GP Microtome Blades TissueStor Tubs Sliderite Slide Mailers CELLSTOR POT & LID ClariTex Coverslips CellTec Section Bath Macro Knives CELLEDGE TRIMMING BLADES Stainless Steel Base Moulds TissueWrap Biopad Biopsy Pads CellTec filters Biopsy Bags CellTec Section Dryer TruSlice TruSlice Digital

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2010-09-10
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2015-12-31
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2015-12-31
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2012-05-18
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2010-09-10
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2015-12-31
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-12-31
KER	Container, Embedding	Pathology	Class 1	864.3010	2010-09-10
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2012-05-18
IDR	Ovens, Paraffin	Pathology	Class 1	864.3010	2015-12-31
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

James Tentler Business: SLMP LLC d.b.a. StatLab Medical Products Email: JTentler@statlab.com Phone: (972) 4361010

Related Public Records

Same Entity

CELLPATH LTD

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
2025606	CalibreScientific US, Inc.	VANCOUVER, WA, US
1000469910	Waldemar Knittel Glasbearbeitungs GmbH	BRAUNSCHWEIG, NIEDERSACHSEN Lower Saxony, DE
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
8044093	Kolplast Ci Ltda	Itupeva Sao Paulo, BR
3008496560	NINGBO GREETMED MEDICAL INSTRUMENTS CO., LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005787343. Last updated year: 2026. Please use registration number 3005787343 when referencing this establishment in official correspondence.