Skip to main content
Home/ Industries/ Healthcare
Health and Life Safety · MDR Class I

Infection control
at the drain level
Where pathogens begin.

Drains in hospitals are not just a sanitary issue. Peer-reviewed literature — including in the Journal of Hospital Infection and Infection Control & Hospital Epidemiology — describes biofilm in traps as an environmental reservoir of resistant organisms such as Pseudomonas aeruginosa and carbapenemase-producing Enterobacterales (CPE), and documents dispersal of trap contents during water flow. Most of that literature concerns the traps of handwash basins and sinks. Green Drain™ is a physical one-way seal; in SGS laboratory testing it blocked >99.9 % of viral aerosols. It is classified as Class I under Regulation (EU) 2017/745, and the manufacturer holds an SRN in EUDAMED.

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, intensive care unit — drains that go unused for longer periods become a stagnant environment in which biofilm grows unchecked. Peer-reviewed literature, including in the Journal of Hospital Infection and the American Journal of Infection Control, has documented healthcare-associated outbreaks linked to drains and traps.

Without Green Drain™

  • The trap runs dry after 2 – 4 weeks of non-use (rooms after discharge, seasonal department closures).
  • 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) — classified as Class I; manufacturer holds an SRN in EUDAMED
  • 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 hospital admissions annually. Every room, every ICU unit, every washroom 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 — manufacturer holds an SRN in EUDAMED
EN 1253
EU standard for floor drains (Parts 1, 6, 7, 8)
HACCP International
Listed under RG-04 for drain control
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 — Regulation (EU) 2017/745 (MDR), Regulation (EC) No 178/2002 (general principles of food law), Regulation (EC) No 852/2004 (food hygiene — HACCP obligation), Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 (food contact materials), Regulation (EU) No 528/2012 (BPR), Directive 2014/34/EU (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), ASSE 1072-2020 (floor drain trap seal protection devices) and NSF/ANSI 2 (food equipment). HACCP International RG-04 is a private certification programme operated by HACCP International, not an official certification issued by a public authority. 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, 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.

Croatian hospitals are built according to EN 1253. P-traps in rooms and sanitary units are predominantly 1.5″ (38 mm) — the most common size. Operating rooms, sterilisation 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
  • 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?

Green Drain™ is classified as Class I under Annex VIII of Regulation (EU) 2017/745 (MDR), and the manufacturer holds a Single Registration Number (SRN) in the European EUDAMED database. For Class I devices that are non-sterile and have no measuring function, the manufacturer self-declares conformity under Annex IV; no notified body is involved and no third-party MDR certificate exists. The product is a mechanical barrier and does not prevent, diagnose, or treat disease.

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 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™ (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.