SZcaremed
by Shenzhen Caremed Medical Technology Co., Ltd. 664 variants
Part of a family of 11 devices: see the family page
Ref IBMR-PVBModel EK10U-NK2-BI
SZcaremed (IBMR-PVB) is a Class I device made by Shenzhen Caremed Medical Technology Co., Ltd., registered in EUDAMED on 14 May 2025 (Basic UDI-DI 69707585ECG01QK), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69707585ECG01QK 06931973449722 | Date14 May 2025 | StatusActive |
Official records
- EUDAMED public site 69707585ECG01QK
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- Withdrawn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
- EKG Cable
- Model / reference
- EK10U-NK2-BI, IBMR-PVB
- Primary DI / UDI-DI
- 06931973449722
- Basic UDI-DI
- 69707585ECG01QK
- EMDN code
- Z12030280 Vital signs monitoring instruments - hardware accessories
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000010579
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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