Annex II of MDR (EU) 2017/745 requires every Class I manufacturer to compile a Technical Documentation file. This page is the public-facing extract: device overview, functional principle, key characteristics, materials, manufacturing and quality systems, and the standards referenced. The complete file is held by Green Drain Europe ApS and provided to competent authorities on request.
Region scope: The MDR classification on this page applies to the European Union only. In the United States, Green Drain is not currently classified as a medical device. The underlying engineering and test data referenced here are part of the global product file, but the medical device regulatory framing is EU-specific. North American certifications are listed on the Certifications page.
Reproduced verbatim from the Technical Summary.
Green Drain is a passive, non-powered mechanical device designed for installation in floor drains. It functions as a one-way barrier that allows the passage of liquids while restricting the upward movement of air and aerosols from drainage systems.
The device contains no electronic components, no software, and does not interact directly with the human body. Technical Summary, Device Overview
The device consists of a flexible elastomer membrane housed within a rigid structure. The mechanism is passive. It operates without external energy and requires no user interaction once installed.
When water or other liquid contacts the membrane from above, downward pressure causes the membrane to open, allowing fluid to drain through the device into the pipe below. The opening force required has been measured at low magnitudes during ASSE 1072 testing.
In the absence of flow, the elastomer membrane returns to a closed position under its own elastic recovery. This creates a physical seal that restricts airflow from the drain through the device.
The geometry of the membrane resists upward pressure from the drain side. Mechanical resistance has been independently verified through testing under standardised pressure conditions documented in the Annex II file.
Device type
Passive mechanical barrier (non-active device)
Sterility
Non-sterile
Measuring function
None
Body contact
No direct or indirect contact with the human body
Integration
Designed for integration into standard drainage systems
Variants available
Eight pipe sizes, GD125 through GD6 (DN32 to DN150)
The device has been evaluated using standardised laboratory and technical testing methods. Each method was carried out under controlled testing conditions; performance data must be interpreted within that context.
Drainage flow rates measured under controlled pressure and volume. Documented in independent laboratory test reports including the IAPMO R&T file under ASSE 1072-2020 and the Danish Technological Institute reports under EAD 180020-00-0704.
Long-term durability tested through repeated open-close cycling under controlled temperature conditions. Measurement methods include accelerated cycle testing and post-cycle integrity inspection.
Dimensional checks against design specifications, batch-to-batch consistency monitoring, and incoming material verification under the manufacturer's quality management system.
Packaging verified to maintain device integrity through standard distribution conditions. Storage requirements are documented in the IFU.
Laboratory testing using aerosol surrogate models has demonstrated a high level of containment under controlled conditions. Underlying test data is held in the SGS Pathogen Test report. View the SGS Pathogen Test page for details.
All performance data are derived from controlled testing environments and should be interpreted within that context.
Housing
ABS polymer
Membrane
Silicone-based elastomer
Latex content
No information indicating the presence of natural rubber latex is identified in the available material specifications.
Material safety
NSF/ANSI 2 certified for food equipment material safety
Production is carried out under established quality management systems. Although Class I devices are not required to operate under a medical-device-specific QMS, Green Drain manufacturing has adopted both the general ISO 9001 standard and the medical-device-specific ISO 13485 standard.
The Technical Documentation cross-references several internationally recognised standards. These standards are independent of MDR but reinforce the regulatory file with verified third-party benchmarks.
North American performance standard for barrier-type floor drain trap seal protection devices. Green Drain holds an IAPMO cUPC listing under ASSE 1072-2020. View the cUPC ASSE 1072-2020 certification page.
Australian plumbing standard for waterless trap seal devices. Green Drain is WaterMark certified under this specification. View the WaterMark certification page.
European Technical Assessment under EAD 180020-00-0704 for waterless odour traps, issued by ETA-Danmark A/S. Validates performance characteristics including odour tightness, mechanical resistance, and thermal cycling. View the CE / ETA-18/0536 page.
International standard for the application of risk management to medical devices. Green Drain's Risk Management File is aligned with ISO 14971 principles. The risk management process is iterative across the device lifecycle, including post-market surveillance.
Green Drain is a passive environmental control device. It does not replace established hygiene protocols, cleaning procedures, or infection prevention measures.
Use of the device should be considered as one element within a broader hygiene management framework. Technical Summary, Important Information
Three pages, version 1.1, status Public, issued 20 April 2026 by Green Drain Europe ApS. Public extract of the Annex II Technical Documentation. Designed for technical specifiers, including architects, engineers, and infection prevention consultants.
The manufacturer's signed declaration that Green Drain conforms to MDR (EU) 2017/745. Identifies all 8 device variants by UDI-DI and is the primary regulatory document for distributors and competent authorities.
User-facing document under MDR Annex I, Section 23. Identification, intended purpose, installation steps, warnings, maintenance, and full UDI-DI table for all 8 variants.
Plain-language explanation of the regulatory position: classification, why MDR applies, conformity route, EUDAMED registration, and explicit scope and limitations.
The complete Annex II Technical Documentation file is held by the manufacturer and provided to competent authorities and qualified specifiers on request. Engineering can also provide spec language and project-specific submittals.