← Back to catalogue
Antireflux Drainage Bags
EUDAMEDClass I (EU MDR)
Ref REFModel 500mL、1000mL、1500mL、2000mL
Identity
- Device Name
- Antireflux Drainage Bags EUDAMED
- Model / Reference
- 500mL、1000mL、1500mL、2000mL EUDAMEDREF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974269820218 EUDAMED
- Basic UDI-DI
- 697426982DB01L7 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
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
Category: Negative-pressure wound therapy system canister
Antireflux Drainage Bags by Baihe Medical Technology (Wuhan) 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
- Sacca 600 ml circuito chiuso c/filtro — Redax S.p.A. · 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 | 697426982DB01L7 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baihe Medical Technology (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025832
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED f25719a6-ad2f-45e4-9946-e87040777c88 61 fields · synced Jun 18, 2026