Digital Blood Pressure Monitor Prolife PC5 Comfort AF
by Globalcare Medical Technology Co., Ltd.
Ref 93171
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697022925GCE6XXEB 06970229254192 | Date9 Aug 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Blood pressure measuring equipment
- Model / Reference
- 93171
- Primary DI / UDI-DI
- 06970229254192
- Basic UDI-DI
- 697022925GCE6XXEB
- Direct Marketing DI
- 06970229254192
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- EU market of registration
- Lithuania
Manufacturer details
- EUDAMED SRN
- CN-MF-000033595
- Authorised representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No