Blood Pressure Cuffs
by Tianchang Xinhui Garment Co., Ltd 18 variants
Ref ML(22-42cm)Model S（16-24CM）S(15-26cm) M（22-36CM） L (22-42CM) XL(30-42CM)XL(32-48cm)XL(40-55cm)XXL (40-56 cm)
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 | Number697605454BPC01FW 06976054540103 | Date6 Nov 2023 | 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- Withdrawn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 Cuffs
- Model / Reference
- S（16-24CM）S(15-26cm) M（22-36CM） L (22-42CM) XL(30-42CM)XL(32-48cm)XL(40-55cm)XXL (40-56 cm), ML(22-42cm)
- Primary DI / UDI-DI
- 06976054540103
- Basic UDI-DI
- 697605454BPC01FW
- Direct Marketing DI
- 06976054540103
- EMDN Code
- Z12030285 Vital signs monitoring instruments - consumables
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027763
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Tianchang Xinhui Garment 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