Identity
- Trade Name
- SBM 35 EUDAMED
- Device Name
- Blood pressure measuring equipment EUDAMED
- Model / Reference
- 860.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970229255342 EUDAMED
- Basic UDI-DI
- 697022925GCE6XXEB EUDAMED
- Direct Marketing DI
- 06970229255342 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sbm 35 by Globalcare Medical Technology Co., Ltd. — Class IIa — 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 | 697022925GCE6XXEB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Globalcare Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033595
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (1)
- EUDAMED 5ed398c3-dcbf-43bd-9f00-06ffad76ef69 61 fields · synced Aug 1, 2026