Biossays Albumin (Bromocresol Green)
by Shenzhen New Industries Biomedical Engineering Co., Ltd.
Ref 130552009A
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69471455588X8 06947145584108 | Date27 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Albumin (Bromocresol Green)
- Model / Reference
- 130552009A
- Primary DI / UDI-DI
- 06947145584108
- Basic UDI-DI
- 69471455588X8
- EMDN Code
- W01010201 Albumin (cc)
- Device Class
- Class B
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000005655
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No