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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
- 06974269820256 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
Antireflux Drainage Bags by Baihe Medical Technology (Wuhan) 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 | 697426982DB01L7 | Class I | Active |
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Manufacturer
- Manufacturer
- Baihe Medical Technology (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025832
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 582aad9c-c556-43e4-b319-10478f98e5b7 61 fields · synced Oct 7, 2026