Instructions for Use (IFU)

User-facing instructions required under MDR Annex I, Section 23.

The Instructions for Use is the document that accompanies every Green Drain unit placed on the EU market. It identifies the device, states its intended purpose, sets out installation steps, warns of limitations, and explains maintenance, removal, disposal, and traceability. Version 1.1, issued 20 April 2026 by Green Drain Europe ApS.

Why the IFU is required.

Section 23 of Annex I of MDR (EU) 2017/745 sets out the requirements for the information that must be supplied with every medical device. The Instructions for Use is the principal piece of that information for any device that is not so simple that the IFU can be omitted. For Green Drain it covers identification, intended purpose, intended users, installation, warnings and limitations, maintenance, removal, disposal, materials, storage, and traceability.

The IFU is written for the people who actually handle the device: facility staff, technical service providers, and installers. It is not a marketing document. It does not promise outcomes that the device cannot deliver. It records what the device is, what it does, what it does not do, and how to use it correctly.

Device identification.

Product name

Green Drain

Device type

Passive mechanical drain trap seal

Variants

GD125 through GD6 (eight pipe sizes)

Manufacturer

Green Drain Europe ApS
Birk Centerpark 40, DK-7400 Herning, Denmark

Single Registration Number (SRN)

DK-MF-000052289

Document version

v1.1, issued 20 April 2026, status: Public

Intended purpose.

Reproduced verbatim from the IFU, Section 2.

Green Drain is a non-invasive, passive device intended for installation in floor drain systems within built environments, including healthcare facilities.

The device functions as a mechanical barrier to reduce environmental exposure to air and aerosolised particles originating from drain systems, under defined conditions of use.

Green Drain is intended to support hygiene management and infection prevention and control measures by limiting drain-mediated exposure pathways.

The device does not act on the human body and does not achieve its purpose by pharmacological, immunological, or metabolic means. Instructions for Use, Section 2 (Intended Purpose)

Intended users and environments.

Installation and maintenance must be performed by trained personnel, such as facility staff or technical service providers. The device is not intended for direct interaction with patients.

Environments of use:

Hospitals
Clinics
Outpatient facilities
Long-term care facilities
Other built environments with floor drain systems

Installation, in five steps.

From the IFU, Section 4. The device must be correctly seated and stable within the drain system before completing installation.

Removing the existing drain grate to expose the drain opening

Step 1

Remove existing drain grate

Lift out the grate to expose the drain opening. Set the grate and any screws aside in a safe place; you will reinstall these once the device is in position.

Inserting the Green Drain into the drain opening with the silicone skirt pointing down

Step 2

Insert Green Drain into the drain opening

Position the device with the silicone skirt downward and push it straight into the drain opening. The flexible housing compresses slightly for a friction fit inside the pipe; no adhesive or sealant is required.

Recessing the Green Drain 2 to 4 inches into the physical pipe

Step 3

Position within the pipe as appropriate

The IFU diagram indicates a recess of 2" to 4" into the physical pipe, depending on drain configuration. Recessing keeps the device clear of the grate above and lets the original grate sit flush.

Replacing the original drain grate over the installed Green Drain

Step 4

Replace and close the drain grate

Reseat the original grate over the device. Because the Green Drain sits inside the pipe, the grate fits exactly as it did before, with no visible change to the drain.

Fastening screws to secure the drain grate

Step 5

Secure using screws if applicable

Some grates require screws to lock in place. Many floor drains use gravity-set grates that do not require screws. Either way, confirm the device remains correctly positioned after fastening.

A complementary general installation guide is available on the Installation Guide page.

Warnings and limitations.

Reproduced from the IFU, Section 5. These boundaries are explicit. The device is regulated as a Class I medical device on the basis of supporting hygiene programs through environmental control. It is not regulated as a treatment.

Green Drain is a passive environmental control device and does not prevent, diagnose, treat, or cure disease.

The device does not replace established hygiene protocols, cleaning procedures, or infection prevention measures.

No claims are made regarding reduction of infection rates or patient outcomes.

Performance depends on correct installation and appropriate use within a broader hygiene management framework.

The device is not intended for direct interaction with patients.

Use, maintenance, removal, and disposal.

Use and handling

The device operates automatically once installed. No active user interaction is required during normal operation. Ensure the device remains properly positioned within the drain.

Maintenance and inspection

Periodically inspect for correct positioning and integrity. Remove and reinstall if displacement is observed. Replace the device if visible damage or degradation occurs.

Removal

Remove the drain grate, extract the device from the drain, and inspect, clean, or replace as necessary.

Disposal

Dispose of the device in accordance with local regulations. If contamination (for example biofilm or hazardous substances) is suspected, handle and dispose of as potentially contaminated waste.

Storage prior to installation

Store in a clean, dry environment. Avoid exposure to extreme temperatures or mechanical stress prior to installation.

Materials.

From the IFU, Section 10. Material identification supports procurement specifications, particularly in healthcare environments where latex declarations are routinely required.

Housing

ABS polymer

Membrane

Silicone-based elastomer

Latex content

No information indicating the presence of natural rubber latex is identified in available material specifications.

Traceability and UDI-DI.

Each device or packaging unit includes identification allowing traceability through batch or lot number. The Unique Device Identifier - Device Identifier (UDI-DI) for each variant is below. The Basic UDI-DI groups all variants under a single product family identifier.

Basic UDI-DI

5745001471GreenDrainMDRJD

Variant	Pipe Size	UDI-DI
GD125	1.25" / DN32	05745001471002
GD15	1.5" / DN40	05745001471019
GD2	2" / DN50	05745001471026
GD3	3" / DN80	05745001471033
GD35	3.5" / DN90	05745001471040
GD4	4" / DN100	05745001471057
GD5	5" / DN125	05745001471064
GD6	6" / DN150	05745001471071

Public Document

Instructions for Use

Four pages, version 1.1, status Public, issued 20 April 2026 by Green Drain Europe ApS. Required to accompany every Green Drain unit placed on the EU market.

Device identification with manufacturer and SRN
Verbatim intended purpose statement
Intended users and environments of use
Step-by-step installation instructions with diagrams
Warnings, limitations, maintenance, removal, disposal
Materials and storage requirements
Full UDI-DI table for all 8 variants

Download PDF

Need installation training or technical support?

For training resources, video walkthroughs, or technical questions, the engineering team is available. EU specifiers can also request additional installation documentation tailored to specific drain configurations.

Contact Engineering General Installation Guide