SPO2 adapeter cable
by Solaris Medical Technology, Inc United States(FDA 510(k) applicant) EUDAMED
Ref AC031-240183(1)GModel AC032-240075 EMDN Z12030280
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6900234AC001FW | Date19 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AC032-240075, AC031-240183(1)G
- Primary DI / UDI-DI
- 06900234400383
- Basic UDI-DI
- 6900234AC001FW
- EMDN Code
- Z12030280 Vital signs monitoring instruments - hardware accessories
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000038492
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Solaris Medical Technology, Inc.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 0115c7b2-2254-4808-9d87-30d9c4854bed