← Back to catalogue
Enema irragation bag
EUDAMEDClass I (EU MDR)
Ref 1750mlRef 2500mlRef 1500mlRef 2000ml
Identity
- Device Name
- Enema irragation bag EUDAMED
- Model / Reference
- 1750ml EUDAMED2500ml EUDAMED1500ml EUDAMED2000ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975498580065 EUDAMED06975498580096 EUDAMED06975498580072 EUDAMED06975498580089 EUDAMED
- Basic UDI-DI
- 69754985800006AB 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
- 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
Category: Negative-pressure wound therapy system canister
Enema irragation bag by K-Med Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system canister.
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- Dual filter suction bag 2000 ml — Serres Oy · Class I
- PLASTI-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class I
- Sacca 600 ml circuito chiuso s/rubinetto — Redax S.p.A. · Class I
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- Suction liner 2000ML (without shut-off filter, pre-loaded SAP) — Yung Kang Medical Device Technology Co., Ltd. · Class I
- YDC Suction liner with shutoff filter with solidifying agent 2000ml — Shijiazhuang Yuanding Medical Device Co.,LTD · Class I
- Silicone Reservoir — Hangzhou Fushan Medical Appliances Co., Ltd. · Class I
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 | 69754985800006AB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K-Med Co., Ltd
- EUDAMED SRN
- CN-MF-000024689
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED a1e48e4c-3ce5-4da1-8b64-ee8aad4eb036 61 fields · synced Oct 6, 2026
- EUDAMED e63038d6-d41a-443f-98d6-a65db394b008 61 fields · synced May 18, 2026
- EUDAMED 3b7c09c2-9df9-4dd9-8d78-3693582d115d 61 fields · synced May 18, 2026
- EUDAMED 943ff261-279c-4bcd-a9ba-4f6a96351a77 61 fields · synced May 19, 2026