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sanitayaki
EUDAMEDClass IIa (EU MDR)
Ref 06953825907112Model U81CHRef 06953825907105Model U81Q
Identity
- Trade Name
- sanitayaki EUDAMED
- Device Name
- Digital Blood Pressure Monitors EUDAMED
- Model / Reference
- U81CH EUDAMED06953825907112 EUDAMEDU81Q EUDAMED06953825907105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825907112 EUDAMED06953825907105 EUDAMED
- Basic UDI-DI
- B-06953825907112 EUDAMEDB-06953825907105 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
sanitayaki by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06953825907112 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018740
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3cc4e623-ebc8-4116-b4be-e2d109072fd4 61 fields · synced Jul 18, 2026
- EUDAMED 5cc0cf92-ac7f-4963-901e-910dcb9d6b8b 61 fields · synced May 18, 2026