Stom-1190
by Matsunami Glass Ind., Ltd. 6 variants
Ref STOM-11, TOM-11Model TOMO IHC Adhesive Glass Slide, IHC Adhesive Glass Slide
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 | Number494624742STOMP9 04946247425205 | Date16 Dec 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- Withdrawn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
- Trade Name
- TOMO IHC Adhesive Glass Slide
- Device Name
- Stom-1190Microscope Slide
- Model / Reference
- TOMO IHC Adhesive Glass Slide, STOM-11, IHC Adhesive Glass Slide, TOM-11
- Primary DI / UDI-DI
- 04946247425205
- Basic UDI-DI
- 494624742STOMP9, 494624742IHC0GB
- EMDN Code
- W0503900201 Microscope slides
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000023949
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Matsunami Glass Ind., Ltd.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No