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Sleep Apnoea Breathing Therapy Devices(BiPAP Devices)
EUDAMEDClass IIa (EU MDR)
Ref 6632Model DM28-25S-B
Identity
- Trade Name
- Sleep Apnoea Breathing Therapy Devices(BiPAP Devices) EUDAMED
- Device Name
- Sleep Apnoea Breathing Therapy Devices(BiPAP Devices) EUDAMED
- Model / Reference
- DM28-25S-B EUDAMED6632 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972955510061 EUDAMED
- Basic UDI-DI
- B-06972955510061 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sleep Apnoea Breathing Therapy Devices(BiPAP Devices) by Shenzhen Yamind Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972955510061 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yamind Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031941
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 0bcf69ec-5bfc-4261-99de-7cb986a0f33d 61 fields · synced Jun 18, 2026