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Positive Airway Pressure Device
EUDAMEDClass IIa (EU MDR)
Ref 094Model CA720MRef 093Model CA720WRef SV825MModel CA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830ProModel CA720W、CA720M、CA720、BA725W、BA725M、BA725、ST720、ST725W、ST725M、ST725、ST730W、ST730M、ST730、AU730W、AU730MRef ST725MRef ST720Ref AU830ProRef BA825Ref BA725Ref CA820WRef BA825WRef ST830
Identity
- Trade Name
- Positive Airway Pressure Device EUDAMEDPositive Airway Pressure Device, EUDAMED
- Device Name
- Positive Airway Pressure Device EUDAMED
- Model / Reference
- CA720M EUDAMED094 EUDAMEDCA720W EUDAMED093 EUDAMEDCA820M，CA820W，CA820，BA825M，BA825W，BA825，SV825M，SV825W，ST830M，ST830W，ST830，AU830Pro EUDAMEDSV825M EUDAMEDCA720W、CA720M、CA720、BA725W、BA725M、BA725、ST720、ST725W、ST725M、ST725、ST730W、ST730M、ST730、AU730W、AU730M EUDAMEDST725M EUDAMEDST720 EUDAMEDAU830Pro EUDAMEDBA825 EUDAMEDBA725 EUDAMEDCA820W EUDAMEDBA825W EUDAMEDST830 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971914890947 EUDAMED06971914890930 EUDAMED06971914891142 EUDAMED06971914891012 EUDAMED06971914890992 EUDAMED06971914891197 EUDAMED06971914891135 EUDAMED06971914890985 EUDAMED06971914891098 EUDAMED06971914891128 EUDAMED06971914891180 EUDAMED
- Basic UDI-DI
- B-06971914890947 EUDAMEDB-06971914890930 EUDAMED697191489VEN8SU EUDAMED697191489VEN3SJ EUDAMED
- Direct Marketing DI
- 06971914891142 EUDAMED06971914890947 EUDAMED06971914891012 EUDAMED06971914890992 EUDAMED06971914891197 EUDAMED06971914891135 EUDAMED06971914890985 EUDAMED06971914891098 EUDAMED06971914891128 EUDAMED06971914891180 EUDAMED06971914890930 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Positive Airway Pressure Device by Guangzhou Hypnus Healthcare Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971914890947 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971914890947 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Hypnus Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000035782
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (13)
- EUDAMED 04efc793-971d-401b-922b-7bb0e8488741 61 fields · synced Sep 18, 2026
- EUDAMED 5c892a35-02ab-4ee7-a278-0693fc393add 61 fields · synced May 18, 2026
- EUDAMED 40a6b269-8724-4f0f-a70e-7c8232d8fb75 61 fields · synced Jun 18, 2026
- EUDAMED a6b5f834-0a70-4c44-9be4-b84f2cf2117e 61 fields · synced Jun 19, 2026
- EUDAMED c9f0f2f8-cb8f-4fe2-a247-79c1afdc8420 61 fields · synced Jul 13, 2026
- EUDAMED f0536720-a15d-4970-8cd3-f0c619896fe1 61 fields · synced Jul 14, 2026
- EUDAMED cb9f2dbd-e909-48cb-8444-0c85f859f6e1 61 fields · synced Jul 19, 2026
- EUDAMED 23d98fe9-377c-4afb-81fa-9631ffbcfc55 61 fields · synced Jul 22, 2026
- EUDAMED 410261d8-d48c-4dff-b8a1-254ca1d5f4cc 61 fields · synced Jul 22, 2026
- EUDAMED 4f6c50a0-d159-4435-b029-4af3f88c37c3 61 fields · synced Jul 25, 2026
- EUDAMED 7d24be87-8872-426d-a069-32e370af3047 61 fields · synced Jul 29, 2026
- EUDAMED 199ce8bb-b269-4670-ba00-b14ba4491d34 61 fields · synced Aug 2, 2026
- EUDAMED 77520d1a-60c3-4278-9e15-cce83a5a928c 61 fields · synced Sep 18, 2026