Resable fetal transducer belt/CTG belt, gray, 6cm*1500cm, rolled. Resable fetal transducer belt/CTG belt, gray, 6cm*150cm.
by Dongguan Belcare Medical Technology Co., Ltd. 2 variants
Ref B07Model B07, B08
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 | Number697657112RCB001HL 06976571120109 | Date19 Sep 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- Withdrawn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
- Resable fetal transducer belt/CTG belt, gray, 6cm*1500cm, rolled. Resable fetal transducer belt/CTG belt, gray, 6cm*150cm.
- Model / Reference
- B07, B08
- Primary DI / UDI-DI
- 06976571120109
- Basic UDI-DI
- 697657112RCB001HL
- EMDN Code
- Z12030285 Vital signs monitoring instruments - consumables
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000035398
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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