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Health and Life Safety · MDR Class I

Infection control
at the drain level.
Where pathogens begin.

Floor drains in hospitals are not just a sanitary issue — the biofilm in the P-trap has been documented as a reservoir of resistant strains such as Pseudomonas aeruginosa, CRE, and Klebsiella pneumoniae. Studies published in the Journal of Hospital Infection show aerosolisation of pathogens when water is flushed. Green Drain™ is a physical one-way seal with SGS-proven blocking of >99.9 % of viral aerosols, registered in EUDAMED as a Class I medical device (EU 2017/745).

EU 2017/745 MDRSGS >99.9 % blockageHACCP Int. RG-04NSF/ANSI 2EN 1253
>99.9 %
Aerosol Blockage · SGS
0
Water in the P-trap
5 years
Lifespan
30 s
Installations per drain
Problem & solution

The P-trap is the weakest point in healthcare infection control.

Hospital rooms, bathrooms, ICUs — every floor drain after patient discharge or extended room vacancy exposes the space to pathogen aerosolisation. Literature published in the Journal of Hospital Infection and the American Journal of Infection Control has documented drain-associated outbreaks across acute settings.

Without Green Drain™

  • The P-trap dries out within 5–10 days of non-use (isolation rooms between patients, decommissioned wards, refurbishment zones).
  • Each time water is released, the biofilm on the P-trap wall releases aerosolised pathogens into the room.
  • Pseudomonas aeruginosa, CRE, and Klebsiella pneumoniae colonise P-traps and are resistant to conventional disinfectants.
  • ICUs with their own sanitary facilities have been documented as a source of outbreaks in the professional literature.
  • Audits require a written procedure for controlling environmental sources and evidence of its implementation.

With Green Drain™

  • Physical one-way barrier — works even when the floor drain is completely dry.
  • SGS laboratory test (QDF25-0049810-01): >99.9 % blockage of viral aerosols on MS2 bacteriophage surrogate
  • EU 2017/745 (MDR) — registered in EUDAMED as a Class I medical device
  • No chemicals, no plumbing work — installs in 30 seconds per drain.
  • Resistant to common hospital disinfectants (chlorine up to 5 %, quaternary amines, isopropanol, ethanol)
Ireland — sector data

Capacity of the HSE hospital network.

The HSE-funded network includes HSE-run acute hospitals and Section 38 voluntary hospitals (the Mater, St James's, Beaumont, Tallaght, the UHL Group and others), serving thousands of inpatient beds nationwide. Every ward, every ICU, every isolation room and every staff washroom has floor drains that represent a potential vector for HCAI under HSE SARI guidelines.

HSE
Acute hospital network nationwide
Section 38
Voluntary hospitals funded by HSE
Community
HSE community and specialist sites
EU 2017/745
MDR Class I — registered in EUDAMED
EN 1253
EU standard for floor drains (Parts 1, 6, 7, 8)
HSE SARI
National AMR guidelines — drain hygiene aligned
Data Sources and Regulatory Framework (2024–2025 data)

Statistical data taken from official Irish and EU sources: Central Statistics Office Ireland (cso.ie), Health Service Executive (hse.ie), Fáilte Ireland (failteireland.ie), Bord Bia (bordbia.ie), IDA Ireland (idaireland.com), Health Products Regulatory Authority (hpra.ie). Regulatory framework: EUR-Lex for EU directives — EU 2017/745 (MDR), EU 178/2002 (food safety), EU 1935/2004 and EU 10/2011 (food contact materials), EU 528/2012 (BPR), EU 2014/34 (ATEX). Standards: EN 1253-1 (floor P-traps, water seal ≥50 mm), EN 1253 Parts 6/7/8 (gullies with a water seal below 50 mm, with mechanical closure, and combined types; 2023 editions), HACCP International RG-04, ASSE 1072-2020, NSF/ANSI 2, HSE SARI guidelines. Revision date: May 2026.

Implementation

From audit to of the entire department in 14 days.

Our technical team works with the epidemiologist, the chief nurse, and the technical service — from mapping to delivery.

01

Audit

The technician maps all drains (rooms, bathrooms, washroom blocks, kitchen blocks). We measure the internal diameter and the type of grate.

02

Recommendation

Written recommendation with sizes (GD 1.25 to GD 6), total number of pieces, and specification according to EN 1253-1.

03

Test

We place samples in five representative rooms for seven days. Your infection control lead assesses the effect on swab results.

04

Implementation

Your maintenance team can do a whole department in a day. No downtime, no plumber, and nothing to come back for.

Model Recommendation

Recommended sizes by area of the hospital.

Irish HSE hospitals are typically built to EN 1253 standard. P-traps in patient rooms and sanitary units are predominantly 1.5″ (38 mm) — the most common size. Operating theatres, sterilisation areas, and central kitchen drains use larger diameters. A typical acute hospital requires four to five different sizes throughout the building.

Green Drain™ Recommended for your industry.

  • Hospital rooms and en suite bathroomsGD 1.5
  • ICUs and isolation roomsGD 3.5
  • Operating theatres (central drain)GD 4 or GD 5
  • Hospital kitchen and sterilisation area (CSSD)GD 4 or GD 5
💬 Not sure of the exact size? Send us a photo of your sink drain — our technical team will respond with a written recommendation within the same business day, free of charge.
Check out Green Drain™ → Request a quote
GD 1.5
38 mm · rooms, bathrooms
GD 2.5
55–65 mm · older buildings
GD 3.5
89–100 mm · ICU, shower enclosures
GD 4
102–110 mm · kitchens, operating theatres
GD 5
120–135 mm · sterilisation
GD 6
150–156 mm · central channels
Questions

What we get asked most.

Is Green Drain™ a medical device?

Yes. It is registered in the EUDAMED EU database as a Class I medical device under Regulation (EU) 2017/745 (MDR), intended to contribute to infection control in healthcare facilities.

Is Green Drain™ resistant to hospital disinfectants?

Yes. The silicone material is resistant to sodium hypochlorite up to 5 %, quaternary ammonium compounds, isopropanol, and ethanol at standard hospital concentrations. A detailed chemical compatibility list is provided upon request.

How do you clean it?

Use a standard drain disinfectant. The seal is not taken apart or removed for cleaning — treat it exactly as you would a standard U-bend, with a visual check once a month.

How long does it last?

The expected service life is about five years in normal use. Tested to ASSE 1072-2020 for over 2,500 opening and closing cycles.

Complete solution

Three products.
One protection portfolio.

Green Drain™ doesn't work alone — for maximum drain control it's combined with GD Uri-Tabs™ (urinals) and GreenSwirl™ (drain unblocking).

EU MDR 2017/745 · Medical device

Green Drain™ is a
Class I medical device
under EU MDR.

A one-way floor drain valve classified as a Class I medical device under Regulation (EU) 2017/745. Conformity is self-declared by the manufacturer under Annex IV — for Class I devices that are non-sterile and have no measuring function, no notified body is involved. Manufactured under ISO 13485:2016.

🏥
Class I
Classification
MDR risk
EUDAMED
Manufacturer SRN
DK-MF-000052289
⚙️
ISO 13485
Production under
medical QMS
🌍
27 EU countries
Covered
EU Declaration of Conformity
✓ Green Drain™
Acts as a one-way mechanical barrier in floor drains.
Blocks the upward flow of air and aerosols from the sewer network.
Supports infection prevention and control (IPC) programmes.
Reduces pathways of exposure to pathogens through floor drains.
✗ Green Drain™
Does not prevent, diagnose, treat, or cure diseases.
Does not guarantee a reduction in infection rates or clinical outcomes.
Does not replace established hygiene and disinfection protocols.
Does not come into direct or indirect contact with the patient's body.
Why MDR Class I?

Green Drain™ is non-invasive, non-sterile, and without measurement functions — does not come into contact with the body. According to Annex VIII of the MDR classification rules, this places it in the lowest risk level.

Despite the low risk class, manufacturing runs under ISO 13485:2016 — medical device standards — including traceability by lot and change control.

EUDAMED SRN
DK-MF-000052289
Basic UDI-DI
5745001471GreenDrainMDRJD
Certification
ISO 13485:2016 + ISO 9001:2015
Economic operators and regulatory information
ManufacturerGreen Drain (greendrains.com). Conformity information is taken from the manufacturer's documentation.
DistributorGREEN FLOW d.o.o., Savska cesta 41, 10000 Zagreb, Croatia, OIB 92557545052 — distributor within the meaning of Article 14 of Regulation (EU) 2017/745.
ClassificationClass I under Annex VIII of Regulation (EU) 2017/745. Conformity is self-declared by the manufacturer under Annex IV; no notified body is involved and no third-party MDR certificate exists.
Two CE marksCE under Regulation (EU) 2017/745 (medical devices) and, separately, CE under Regulation (EU) 305/2011 (construction products, ETA-18/0536). These are two distinct regimes.
Before useRead the manufacturer's instructions for use. We send the IFU and the Declaration of Conformity on request: info@greenflow.ie.
Incident reportingReport a suspected defect or incident to info@greenflow.ie. We keep a complaints register and forward reports to the manufacturer and the competent authority.

Ready for Free audit?

We come to the site, map the drains, and provide a written recommendation — no cost, no obligation.