May Grunwald Pappenheim
by Bio-Optica Milano S.p.A. 2 variants
Ref 05-12002E, 05-12002/L
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number080339762W0103010301AJ | Date4 Nov 2022 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Staining for histology
- Model / Reference
- 05-12002E, 05-12002/L
- Primary DI / UDI-DI
- 08033976232627, 08033976232610
- Basic UDI-DI
- 080339762W0103010301AJ
- Direct Marketing DI
- 0803397623262708033976232610
- EMDN Code
- W0103010301 Histo / cyto stains
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027525
Other devices from Bio-Optica Milano S.p.A.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No