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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 aerosolization 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 weakest point Infection control in healthcare.

Hospital room, bathroom, ICU unit—each floor drain after patient discharge and during seasonal reduced use exposes the space to the risk of pathogen aerosolization. Literature published in the Journal of Hospital Infection and the American Journal of Infection Control has documented outbreaks of infections associated with drains.

Without Green Drain™

  • The P-trap dries out within 5–10 days of non-use (rooms after discharge, seasonal department closures).
  • Each time water is released, the biofilm on the P-trap wall releases aerosolized pathogens into the room.
  • Pseudomonas aeruginosa, CRE, and Klebsiella pneumoniae colonise P-traps and are resistant to conventional disinfectants.
  • ICU units 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)
Croatia — verified data

Capacity of the Croatian hospital system

According to data from the Croatian Institute of Public Health, the Croatian hospital system handles over 631,000 hospitalizations annually. Every room, every ICU unit, every restroom has floor drains that represent a potential vector for infection.

21.795
Hospital Beds in Croatia (HZJZ 2024)
631.249
Annual Hospitalization (HZJZ 2024)
1.35 million
Visits to Day Hospitals (HZJZ 2024)
EU 2017/745
MDR Class I — registered in EUDAMED
EN 1253
EU standard for floor drains (Parts 1, 6, 7, 8)
HACCP International
RG-04 endorsement as a drainage control measure
Data Sources and Regulatory Framework (2024–2025 data)

Statistical data were taken from official sources: State Statistical Office (data.dzs.hr) Croatian Institute of Public Health (hzjz.hr), Ministry of Labor, Pension System, Family and Social Policy (mrosp.gov.hr), Agency for Science and Higher Education (azvo.hr), Ministry of Tourism and Sports (mint.gov.hr). Regulatory framework: EUR-Lex for EU directives and regulations — 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 (mechanical seal failures, 2023), HACCP Internacional RG-04, ASSE 1072-2020, NSF/ANSI 2. Tourism data taken from the DZS publication for H1 2025, healthcare data from the HZJZ report 2024, data for education from DZS publications for the 2023/2024 and 2024/2025 school years, data for nursing homes from the MROSP report, and announcements of EU-funded construction in 2025. 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, sanitary nodes, 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 epidemiologist assesses the effect on the swabs.

04

Implementation

The technical service installs an entire department in a single day of work. No downtime, no plumber. No intervention for years.

Model Recommendation

Recommendation per type of space in the hospital

Croatian hospitals are built according to EN 1253. P-traps in rooms and sanitary units are predominantly 1.5″ (DN40) — the most common size. Operating rooms, sterilization areas, and central kitchen drains are larger in size. A typical KBC facility requires four to five different sizes throughout the building.

Green Drain™ Recommended for your industry.

  • Hospital rooms and en suite bathroomsGD 1.5
  • ICU units and isolation roomsGD 3.5
  • Operating rooms (centre aisle)GD 4 or GD 5
  • Hospital kitchen and sterilization 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
DN40 · rooms, bathrooms
GD 2.5
DN65 · older objects
GD 3.5
DN90 · ICU, shower enclosures
GD 4
DN100 · kitchens, operating rooms
GD 5
DN125 · sterilization
GD 6
DN150 · central grooves
Questions

Most common doubts

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 disassembled or removed for cleaning—it's treated the same as a standard U-bend. Perform a visual inspection once a month.

How long does it last?

The expected lifespan is 5 years under normal use. ASSE 1072-2020 is tested 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™ (cleaning).

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) programs
Reduces pathways of exposure to pathogens through floor drains.
✗ Green Drain™
Does not prevent, diagnose, treat, or cure diseases.
It 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 its low class, the production system is satisfactory. 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.