Blood Pressure Cuff
by Xiamen Ants-Bro Technology Co., Ltd. 2 variants
Ref GBS-13Model GBS-17, GBS-17-42, GBS-11, GBS-12, GBS-13, GBS-11-C, GBS-17-36, GBS-17-43, GBS-17-42G
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69477077GBS75 06947707703992 | Date6 Dec 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Blood Pressure Cuff
- Model / Reference
- GBS-17, GBS-17-42, GBS-11, GBS-12, GBS-13, GBS-11-C, GBS-17-36, GBS-17-43, GBS-17-42G
- Primary DI / UDI-DI
- 06947707703992
- Basic UDI-DI
- 69477077GBS75
- EMDN Code
- Z12030285 Vital signs monitoring instruments - consumables
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000010562
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiamen Ants-Bro Technology Co., Ltd.
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No