Identity
- Trade Name
- KLYSO EUDAMED
- Device Name
- MEDICAL ENEMATOR EUDAMED
- Model / Reference
- LY-ET04 EUDAMED61001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394401624 EUDAMED
- Basic UDI-DI
- 697539440LYET00WD EUDAMED
- EMDN Code
- G02060303 BALLOON CATHETERS, BARIUM ENEMA 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
Klyso by Linye Health Tech(ningbo)co., Ltd — Class I — 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 | 697539440LYET00WD | Class I | Active |
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Manufacturer
- Manufacturer
- Linye Health Tech(ningbo)co., Ltd
- EUDAMED SRN
- CN-MF-000024232
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED b15f3de6-1fdc-48fd-851f-a1628b5195e9 61 fields · synced Oct 6, 2026