Identity
- Device Name
- Spacers For Aerosol EUDAMED
- Model / Reference
- 155ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977334880070 EUDAMED
- Basic UDI-DI
- 697733488SFA01QQ EUDAMED
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Spacers For Aerosol by Ningbo Seasight Medical Instruments 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 | 697733488SFA01QQ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Seasight Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032275
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 133fff7b-a72b-4064-8fc4-e838e4e3e111 61 fields · synced Jul 11, 2026