Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010162618

FEI Number

3010162618

Entity Name

GP MEDICAL DEVICES A/S

City/State/Country

Holstebro Midtjylland, DK

Establishment Address

Nupark 51, Holstebro Midtjylland DK-7500, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GP MEDICAL DEVICES A/S (Owner Number: 10042313)

Owner / Operator Contact Address

Nupark 51, Holstebro, DK-82 DK-7500, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

12 60 10 EasySampler Mini Kit 12 01 00 EasySampler Single 14 01 00 EasySampler Urine and Stool Collector 13 10 00 EasySampler BASIC Stool Collector Bulk 13 01 00 EasySampler BASIC Stool Collector 12 01 02 EasySampler HAT 13 10 70 EasySampler BASIC Stool Collector DIA 12 10 00 EasySampler Single Bulk EasyDrainer EZ-Sampler Complete kit EasySampler Stool Collection Kit 12 70 00 EasySampler Complete Stool Collection Kit EasySampler AIR Kit (12 70 00 AIR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-09-01
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-02-29
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2018-02-20

Official Correspondent

Henning Hedegaard

US Agent Details

Jim Richard Business: Americal Laboratory Products Company, Ltd. Email: Jrichard@alpco.com Phone: (603) 6812568

Related Public Records

Same Entity

GP MEDICAL DEVICES A/S

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010162618. Last updated year: 2026. Please use registration number 3010162618 when referencing this establishment in official correspondence.