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Respiratory accessories
EUDAMEDClass I (EU MDR)
Ref A10200-011Ref C10200-023Ref A10200-032
Identity
- Device Name
- Respiratory accessories EUDAMED
- Model / Reference
- A10200-011 EUDAMEDC10200-023 EUDAMEDA10200-032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712688054515 EUDAMED04711064683783 EUDAMED04712688050388 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
- Greece EUDAMEDSpain EUDAMEDCyprus 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 (3)
- EUDAMED cf9f8f08-f70b-42f2-b941-155d8b536e03 61 fields · synced Jul 28, 2026
- EUDAMED 0c1778ba-58b5-4024-9e98-329e4703b2bc 61 fields · synced May 17, 2026
- EUDAMED dc85a97d-230e-4c8f-bfc7-52c425454644 61 fields · synced May 19, 2026