Potassium Permanganate Solution (1%)
by Richard-Allan Scientific LLC United States EUDAMEDGUDID
Ref 88046
Product code LEEEMDN W0103010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0673693RAS051RN | Date9 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00673693202251 | Date6 Sep 2024 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Potassium Permanganate Solution (1%) EUDAMEDEpredia GUDID
- Generic Name
- Biological stain IVD
- Device Name
- Reticulin Silver Stain Kit
- Model / Ref / Catalog
- 88046, Potassium Permanganate Solution (1%)
- Primary DI / UDI-DI
- 00673693202251
- Basic UDI-DI
- 0673693RAS051RN
- Direct Marketing DI
- 00673693202251
- FDA Product Code
- LEE
- 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 | 88046 | Potassium Permanganate Solution (1%) |
| 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 7406fd4c-895a-4542-8e82-f64bcd57f1d4
- FDA UDI 47ae8679-438d-4e76-bf8b-cfd858f0fa5b