Hematoxylin 7212
by Richard-Allan Scientific LLC United States EUDAMEDGUDID
Ref 7212
Product code HYJEMDN W0103010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0673693RAS028RT | Date25 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00673693210126 | Date4 Sep 2024 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hematoxylin 7212 EUDAMEDEpredia GUDID
- Generic Name
- Biological stain IVD
- Device Name
- Histology Stains
- Model / Ref / Catalog
- 7212, Hematoxylin 7212
- Primary DI / UDI-DI
- 00673693210126
- Basic UDI-DI
- 0673693RAS028RT
- Direct Marketing DI
- 00673693210126
- FDA Product Code
- HYJ
- EMDN Code
- W0103010301 Histo / cyto stains
- GMDN Term
- Biological stain IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 864.1850
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 7212 | Hematoxylin 7212 |
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000008261
- Authorised representative
- Epredia Netherlands B.V. NL-AR-000001488
Properties & raw data
Show properties, registry sources and raw records
Other properties (17)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
Sources (2)
- EUDAMED 6cd234a8-e9ca-4929-aa07-df2cbabf680a
- FDA UDI da621928-4d15-4455-9259-30639f664d1e