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disposable respiratory gas bubble humidifier
EUDAMEDClass I (EU MDR)
Ref SD-H01Model SD-H01
Identity
- Device Name
- disposable respiratory gas bubble humidifier EUDAMED
- Model / Reference
- SD-H01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975338561001 EUDAMED
- Basic UDI-DI
- 697533856humidifierGN EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES 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
disposable respiratory gas bubble humidifier by Wenzhou Shengding Industry & Trade 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 | 697533856humidifierGN | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Shengding Industry & Trade Co., Ltd
- EUDAMED SRN
- CN-MF-000009818
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 195772e7-fbf2-45ea-ac60-169b2ae35bc3 61 fields · synced Jul 9, 2026