Identity
- Trade Name
- Hydrobag EUDAMED
- Device Name
- PVC Enteral Feeding Bag for Simple EUDAMED
- Model / Reference
- FS001 EUDAMED7751100 EUDAMED7751102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972261821165 EUDAMED06972261821172 EUDAMED
- Basic UDI-DI
- 697226182FS001CS EUDAMED
- Direct Marketing DI
- 06972261821165 EUDAMED06972261821172 EUDAMED
- EMDN Code
- A080101 ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), 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
Hydrobag by Ucomfor Scientific 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 | 697226182FS001CS | Class I | Active |
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Manufacturer
- Manufacturer
- Ucomfor Scientific Co., Ltd
- EUDAMED SRN
- CN-MF-000016602
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d10aa7c2-79bb-477c-acd8-6fb69758250e 61 fields · synced Oct 6, 2026
- EUDAMED aa4b8230-deb9-41eb-96d1-7f6764d6cb35 61 fields · synced May 19, 2026