Identity
- Device Name
- Disposable Drainage Bag EUDAMED
- Model / Reference
- KTW2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971302780024 EUDAMED
- Basic UDI-DI
- 697130278KTW2000PW 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
Category: Negative-pressure wound therapy system canister
Disposable Drainage Bag by Koshin Hengxin (Jiangsu) Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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 | 697130278KTW2000PW | 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 512baf0a-c804-420b-8c6f-c9f876012302 61 fields · synced Jun 18, 2026