Identity
- Device Name
- XEN Endo EUDAMED
- Model / Reference
- 6036009701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060478112587 EUDAMED
- Basic UDI-DI
- 506047811XV17776X EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Medical device disinfection agent
XEN Endo by Quadralene Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506047811XV17776X | Class I | Active |
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Manufacturer
- Manufacturer
- Quadralene Ltd
- EUDAMED SRN
- GB-MF-000016550
- Authorised Representative
- MAQUET GmbH DE-AR-000009120
Sources (1)
- EUDAMED d9165856-111b-413f-95a5-566e87df33a6 61 fields · synced Oct 6, 2026