PDI EMEA LTD

FDA Device Registration & Listing · Corby Northamptonshire, GB · Registration 3017533431

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017533431
FEI Number
3017533431
Entity Name
PDI EMEA LTD
City/State/Country
Corby Northamptonshire, GB
Establishment Address
Pywell Road, Willowbrook East Industrial Estate, Corby Northamptonshire NN17 7NJ, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PDI EMEA LTD (Owner Number: 10091180)
Owner / Operator Contact Address
Pywell Road, Willowbrook East Industrial Estate, Corby, GB-NTH NN17 7NJ, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2024-08-28

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

PDI EMEA 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-0013-2012 Convatec Inc. 1
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

Registration Number Establishment Name Location
1513988 KUTOL PRODUCTS COMPANY Sharonville, OH, US
3006131984 SEISA MEDICAL INC El Paso, TX, US
3004111573 Sterigenics US LLC Grand Prairie, TX, US
3011707784 CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD. Changshu Jiangsu, CN
3008244559 CASEX, LTDA Curitiba Parana, BR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017533431. Last updated year: 2026. Please use registration number 3017533431 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.