Identity
- Trade Name
- Ostomy Bag EUDAMED
- Model / Reference
- - EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975380920030 EUDAMED
- Basic UDI-DI
- 6975380921120147 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
- Austria 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
Ostomy Bag by Ningbo Risenmed Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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 | 6975380921120147 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Risenmed Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000041539
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED bfc8cc35-abb7-41bc-aed4-bcb6fca54d70 61 fields · synced Jul 16, 2026