Medical Device
Risk-based medical-device frameworks connect intended use, clinical evidence, quality systems and post-market responsibilities.
BES KNOWLEDGE · CERTIFICATION CENTER
BES Certifications
International certifications and regulatory approvals supporting confidence in medical, water-treatment and professional ozone technologies.
5Certification frameworks
22Mapped BES products
1Shared data source
Evidence for different engineering responsibilities
Certifications are not interchangeable badges. Each framework addresses a specific market, product category, safety question or regulatory responsibility.
Water Safety
Drinking-water standards evaluate whether materials and components are suitable for contact with potable-water systems.
International Compliance
Regional conformity and registration pathways support transparent market access and accountable product documentation.
Understand what each certification communicates
The scope below is educational. Always verify the current certificate, listing, intended use and market authorization for the exact product model.
European Economic Area
CE Mark
Conformité EuropéenneThe CE Mark indicates that a manufacturer declares conformity with the EU requirements applicable to that product. It supports lawful placement of covered products on the European market.
- Applicable EU requirements
- Technical documentation
- Declaration of conformity
European Union / EEA
CE MDR
Medical Device Regulation (EU) 2017/745CE MDR applies the European Union medical-device framework, with requirements that extend beyond general CE conformity and follow the device's intended purpose and risk classification.
- Medical Device
- Clinical Evaluation
- Risk Management
- Traceability
- Quality System
North America
NSF/ANSI 61
Drinking Water System Components — Health EffectsNSF/ANSI/CAN 61 establishes health-effects criteria for materials, components, products and systems that contact drinking water. It does not certify general treatment performance.
- Drinking-water contact
- Health-effects criteria
- Material and component evaluation
Australia
TGA (Australia)
Therapeutic Goods AdministrationThe TGA regulates therapeutic goods in Australia. Medical devices generally require appropriate conformity evidence and inclusion in the Australian Register of Therapeutic Goods before lawful supply.
- ARTG inclusion
- Conformity evidence
- Risk-based medical-device regulation
Thailand
Thai FDA
Thai Food and Drug Administration — Medical Device DivisionThai FDA medical-device controls use risk-based classification and require the applicable establishment and product permissions before regulated devices are manufactured or imported commercially.
- Medical Device Division
- Risk classification
- Product registration
Certification scope at a glance
Use this comparison to identify the primary purpose of each framework—not to substitute for certificate review.
| Certification | Region | Purpose | Medical Device | Drinking Water | Required Audit |
|---|---|---|---|---|---|
| CE Mark | European Economic Area | General EU product conformity | No | No | Depends on the applicable EU legislation |
| CE MDR | European Union / EEA | Medical-device conformity | Yes | No | Notified-body involvement depends on device classification |
| NSF/ANSI 61 | North America | Health effects of drinking-water contact materials and components | No | Yes | Third-party testing and certification program |
| TGA (Australia) | Australia | Medical therapeutic-goods market authorization | Yes | No | Assessment rigor and audit depend on device risk and evidence |
| Thai FDA | Thailand | Medical-device establishment and product registration | Yes | No | Regulatory dossier and review depend on device risk class |
BES Product Matrix
Only certifications recorded in productCertifications.ts are displayed. A dash means the certification is not listed in this shared data source.
WDS Series
Medical Products
Others
Filter BES products by certification
Product information and routes are reused from the central BES Product Catalog. Selecting a filter does not alter the certification matrix.
ACTIVE FILTER
22 mapped productsCE Mark
Water Treatment
WDS600X
Inline ozonated water disinfection platform for ice machines, surface sanitation and professional water hygiene workflows.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7177
NSF/ANSI 61: Drinking Water System Components — Health Effects
Water Treatment
WDS1200X
Inline ozonated water disinfection platform for ice machines, beverage systems, surface sanitation and professional water hygiene workflows.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7177NSF/ANSI 61: Drinking Water System Components — Health Effects
Water Treatment
WDS2000X
Inline ozone water system for medium-flow sanitation, surface hygiene and process water applications.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7177NSF/ANSI 61: Drinking Water System Components — Health Effects
Water Treatment
WDS3000X
Advanced ozone water treatment system for higher-capacity professional sanitation applications.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7177NSF/ANSI 61: Drinking Water System Components — Health Effects
Pool / Water Treatment
WDS3000P
Pool-side ozone water treatment concept for side-stream circulation, CT control and water quality support.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7178
Water Treatment
WDS6000X
High-capacity ozone water treatment platform for demanding industrial, food and water sanitation applications.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745; registration group 7178
Dental
ODB
On-site aqueous ozone system designed to support dental unit waterline hygiene, biofilm control, and safer clinical water quality.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745
TGA / ARTG: Australian Register of Therapeutic Goods
Thai FDA: Thai Food and Drug Administration — Medical Device
Dental
CDU
Continuous dental unit waterline disinfection and biofilm control support for dental environments.
CE Mark: Conformité EuropéenneThai FDA: Thai Food and Drug Administration — Medical Device
Aqueous Ozone
COS
Compact ozone spray system for personal hygiene, hand washing, oral care support and small equipment sanitation. COS generates low-dose ozonated water from tap water using electrolysis ozone technology for daily hygiene workflows.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745TGA / ARTG: Australian Register of Therapeutic Goods
Aqueous Ozone
OSB Ozone Spray Bottle
Portable ozone spray bottle designed to generate ozonated water on demand for surface cleaning and daily hygiene applications.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745TGA / ARTG: Australian Register of Therapeutic Goods
Dental / Oral Care
Ozone Oral Rinse Tumbler
Professional ozone oral rinse system clinically supported by SGS laboratory testing. Demonstrated up to 99.999% reduction of P. gingivalis and Streptococcus mutans after only 30 seconds of rinsing. Ozone naturally decomposes into oxygen after use, leaving no chemical residue.
CE Mark: Conformité EuropéenneCE MDR: EU Medical Device Regulation (EU) 2017/745TGA / ARTG: Australian Register of Therapeutic GoodsThai FDA: Thai Food and Drug Administration — Medical Device
Air Hygiene
HAS
Hygienic Air System powered by Electrolytic Ozone Generator (EOG) technology. HAS generates aqueous ozone air from pure water for continuous sanitization, odor reduction and air-conditioning hygiene support without chemical residue or NOx.
CE Mark: Conformité Européenne
Air Hygiene
HAS Mini
Compact humidified ozone air solution for small rooms, treatment zones and local odor control applications.
CE Mark: Conformité Européenne
Air Hygiene
HAS Pro
Professional humidified ozone and hydroxyl air hygiene system for indoor air quality, odor control and commercial applications.
CE Mark: Conformité Européenne
Hydrogen / Ozone Water
HOS
Two-in-one hydrogen and ozone water platform for dental, wellness and hygiene applications.
CE Mark: Conformité Européenne
Hydrogen Water
Hydrogen Pot
Portable hydrogen enriched water pot with optional hydrogen gas delivery for EOS7150-HG, designed for household wellness, warm hydrogen water and premium drinking applications.
CE Mark: Conformité Européenne
Soaking System
WTO
Ozone water generator for soaking, tank preparation and sanitation workflows.
CE Mark: Conformité Européenne
Soaking System
WTO-mini
Compact portable ozone water generator for home, spa, hospital care, pet bathing and small soaking applications.
CE Mark: Conformité Européenne
Water Treatment
OWS
High concentration ozone water system for large pools, storage tanks, cooling towers, production lines and CIP applications.
CE Mark: Conformité Européenne
Ozone Booster System
G-Series
G-Series supplies additional ozone gas to OWS-3 systems, increasing total ozone production capacity for large pools, storage tanks, cooling towers and industrial CIP applications.
CE Mark: Conformité Européenne
Food Safety
Food Purifier
Food washing system for vegetable preparation, kitchen sanitation workflows and operator guidance.
CE Mark: Conformité Européenne
Surface Hygiene
SSS-150
Professional ozone mist surface sanitizing system for hospitals, clinics, offices, hotels and shared equipment hygiene workflows.
CE Mark: Conformité EuropéenneCertification questions
Concise explanations for interpreting the BES matrix and certification terminology.
What is the difference between CE and CE MDR?
CE is the general conformity marking used under applicable EU product legislation. CE MDR refers specifically to conformity under the EU Medical Device Regulation 2017/745 and follows medical-device requirements based on intended purpose and risk classification.
Why doesn't every CE product have CE MDR?
CE MDR applies to products that qualify as medical devices under the regulation. A product may require CE conformity under other EU legislation without being a medical device.
What is NSF/ANSI 61?
NSF/ANSI/CAN 61 establishes health-effects requirements for materials, components and products that contact drinking water. It addresses substances that may be imparted to water; it is not a general certification of treatment performance.
What is TGA?
The Therapeutic Goods Administration regulates therapeutic goods in Australia. Medical devices generally need the appropriate conformity evidence and inclusion in the Australian Register of Therapeutic Goods before lawful supply.
Why are some products registered with Thai FDA?
Thai FDA permissions depend on whether a product is regulated as a medical device and on its risk classification. The applicable establishment and product registration pathway must be followed for regulated products.
Verify the exact model and current document
Certification scope can depend on model, intended purpose, market and certificate validity. Request current documentation when making a regulated purchasing or engineering decision.