Identity
- Trade Name
- FEE BAG EUDAMED
- Device Name
- Feeding Bag (Enteral Feeding Bag) EUDAMED
- Model / Reference
- GS-4042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265404203 EUDAMED
- Basic UDI-DI
- 8907265F003ZA 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
- Austria 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
Fee Bag by Romsons Group Private Limited — 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 | 8907265F003ZA | Class I | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c6b21347-efd8-4f42-8645-e209c6be3ede 61 fields · synced Jul 21, 2026