← Back to catalogue
H1 Hygiene System
EUDAMEDClass I (EU MDR)
Ref 108000010Model Cleaning and disinfection system
Identity
- Trade Name
- H1 Hygiene System EUDAMED
- Device Name
- H1 Hygiene System EUDAMED
- Model / Reference
- Cleaning and disinfection system EUDAMED108000010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9841080000100 EUDAMED
- Basic UDI-DI
- ++D98410018KN EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical utensil washer/disinfector
H1 Hygiene System by METASYS Medizintechnik GmbH — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical utensil washer/disinfector.
- HYDRIM C61WD G4 Instrument Washer-Disinfector — Dent4You AG · Class IIa
- Steelco — STEELCO SPA · Class II
- Antiseptic Applicator — Poly Medicure Limited · Class I
- WD1260-SC-060 — Smeg S.p.A. · Class IIb
- Getinge Aquadis Index — GETINGE DISINFECTION AB · Class IIa
- Sümer — SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIb
- Getinge ED-FLOW AER RANGE — GETINGE DISINFECTION AB · Class IIb
- CS 750 — Belimed Infection Control AG · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D98410018KN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- METASYS Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000014438
Sources (1)
- EUDAMED d8d209ee-1de0-49cb-83f3-b85b987a5d7c 61 fields · synced Oct 7, 2026