Resolve™ Immersion Oil Low Viscosity
by Richard-Allan Scientific LLC 4 variants
Ref M2000
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number0673693RAS013RE 00673693106856 | Date2 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00673693106856 | Date29 Jul 2024 | StatusListed |
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- Withdrawn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
- United States
Specification
- Trade Name
- Resolve™ Immersion Oil Low Viscosity EUDAMEDEpredia GUDID
- Generic Name
- Molecular grade procedure oil IVD
- Device Name
- Immersion Oils
- Model / Ref / Catalog
- M2000, Track 300™ Automated Differential System Immersion Oil
- Primary DI / UDI-DI
- 00673693106856
- Basic UDI-DI
- 0673693RAS013RE
- Direct Marketing DI
- 00673693106856
- FDA Product Code
- PPM
- EMDN Code
- W01030799 Histology / cytology reagents - other
- GMDN Term
- Molecular grade procedure oil IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 864.4010
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | M2000 | Track 300™ Automated Differential System Immersion Oil |
| 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
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