Instant Eosin Alcoholic
by Richard-Allan Scientific LLC United States EUDAMEDGUDID
Ref 6765040
Product code HYBEMDN W0103010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0673693RAS027RR | Date2 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00673693228503 | Date4 Sep 2024 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Instant Eosin Alcoholic EUDAMEDEpredia GUDID
- Generic Name
- Biological stain IVD
- Device Name
- Histology Stains (Eosin)
- Model / Ref / Catalog
- 6765040, Instant Eosin Alcoholic (Series S)
- Primary DI / UDI-DI
- 00673693228503
- Basic UDI-DI
- 0673693RAS027RR
- Direct Marketing DI
- 00673693228503
- FDA Product Code
- HYB
- 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 | 6765040 | Instant Eosin Alcoholic (Series S) |
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000008261
- Authorised representative
- Epredia Netherlands B.V. NL-AR-000001488
Other devices from Richard-Allan Scientific LLC
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 9364ae77-d1bf-4145-b860-8186e3335181
- FDA UDI 294a297d-02a7-46ad-bd56-370cb9ce55d3