Identity
- Trade Name
- Chest Seal EUDAMED
- Device Name
- no EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975380920443 EUDAMED
- Basic UDI-DI
- 697538092204204R EUDAMED
- EMDN Code
- R050280 RESPIRATORY TRACT EXPANSION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Chest Seal by Ningbo Risenmed Technology 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 | 697538092204204R | 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 cc090294-8c2f-458e-b893-77cfc89617a5 61 fields · synced Jul 25, 2026