Blood Sampler
by Edan Instruments, Inc. China EUDAMED
Ref isafeP-3-C5A EMDN A02010502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69444138isafePSBW | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- isafeP-3-C5A
- Primary DI / UDI-DI
- 06944413856202
- Basic UDI-DI
- 69444138isafePSBW
- EMDN Code
- A02010502 Blood gas analysis, syringes with safety needle and kits
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009957
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Edan Instruments, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06944413856202|69444138ISAFEPSBW