Identity
- Trade Name
- Koshin Hengxin EUDAMED
- Device Name
- Disposable Drainage Bag EUDAMED
- Model / Reference
- KCY3000N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971302780096 EUDAMED
- Basic UDI-DI
- 697130278KCY3000NR4 EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Koshin Hengxin by Koshin Hengxin (Jiangsu) Medical 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 | 697130278KCY3000NR4 | Class I | Active |
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Manufacturer
- Manufacturer
- Koshin Hengxin (Jiangsu) Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000042272
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED a4612c18-d7cb-41a8-a899-26d64cdb2c92 61 fields · synced Oct 10, 2026