embedding cassette
by Jiangsu Kahotest Citotest Labware Manufacturing Co., Ltd 2 variants
Ref 16955257416009Model Square holes/stripe holes/round holes/fine square holes/O rings
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 | Number69552574EC001K7 16955257416009 | Date15 May 2023 | 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- Withdrawn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
- embedding cassette
- Model / Reference
- Square holes/stripe holes/round holes/fine square holes/O rings, 16955257416009
- Primary DI / UDI-DI
- 16955257416009
- Basic UDI-DI
- 69552574EC001K7
- EMDN Code
- W0202059004 Tissue embedding processors
- Device Class
- Class A
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000034323
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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