Identity
- Device Name
- Respiratory accessories EUDAMED
- Model / Reference
- 00003456 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711064682939 EUDAMED
- Basic UDI-DI
- 47126880500007258RPASY EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Respiratory accessories by Hsiner 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 | 47126880500007258RPASY | Class I | Active |
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Manufacturer
- Manufacturer
- Hsiner Co., Ltd.
- EUDAMED SRN
- TW-MF-000007258
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 9b7bfccf-5a09-4368-bef2-0ef42506755d 61 fields · synced Jun 19, 2026