Identity
- Model / Reference
- S30101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973280040407 EUDAMED
- Basic UDI-DI
- 697328004S301013K EUDAMED
- EMDN Code
- R900901 INHALERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
S30101 by Hui Zhou Kaiyi 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 | 697328004S301013K | Class I | Active |
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Manufacturer
- Manufacturer
- Hui Zhou Kaiyi Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010394
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 6f916f3d-d13a-4cc1-a56f-add9f8b95396 61 fields · synced Jul 26, 2026