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H1 Hygiene System
EUDAMEDClass I (EU MDR)
Ref 108000002Model Cleaning and disinfection system
Identity
- Trade Name
- H1 Hygiene System EUDAMED
- Device Name
- H1 Hygiene System EUDAMED
- Model / Reference
- Cleaning and disinfection system EUDAMED108000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9841080000020 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
H1 Hygiene System by METASYS Medizintechnik GmbH — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- METASYS Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000014438
Sources (1)
- EUDAMED c338c44e-4477-4a3b-9197-48a9f632dae9 61 fields · synced Oct 7, 2026