Blood Collection Pen(without needle)
by Yongkang Jinkang Health Equipment Factory 11 variants
Ref JK-101-3Model JK-CXB
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 | Number69417552JKBCP001WS 06941755203039 | Date4 Sep 2024 | 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- Withdrawn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 Collection Pen(without needle)
- Model / Reference
- JK-CXB, JK-101-3
- Primary DI / UDI-DI
- 06941755203039
- Basic UDI-DI
- 69417552JKBCP001WS
- EMDN Code
- W0501010203 Blood collection, capillary tubes
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000043945
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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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