Identity
- Trade Name
- Irrigator EUDAMED
- Device Name
- Percutaneous Discectomy Instruments Pack EUDAMED
- Model / Reference
- DCS-JⅠ, DCS-YⅠ EUDAMEDLG01257 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939488502390 EUDAMED
- Basic UDI-DI
- 69394885000FQ4 EUDAMED
- EMDN Code
- K01020120 MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Irrigator by Dragon Crown Medical 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 | 69394885000FQ4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dragon Crown Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000032712
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2942e059-84e6-4c9f-8504-3706ac915592 61 fields · synced Jul 27, 2026