Identity
- Trade Name
- Disposable Hemorrhoids Auto-Ligator EUDAMED
- Device Name
- Disposable Hemorrhoids Auto-Ligator EUDAMED
- Model / Reference
- KYOCA-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970239822954 EUDAMED
- Basic UDI-DI
- 697023982OGT001J5 EUDAMED
- EMDN Code
- G020401 HAEMORRHOID LIGATURE SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable Hemorrhoids Auto-Ligator by Jiangsu Celtics MediTech Co., Ltd. — Class IIa — 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 | 697023982OGT001J5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Celtics MediTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000040688
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED d7b0fb02-5cc3-4c76-826c-29ac521f89de 61 fields · synced Jul 10, 2026