Identity
- Trade Name
- BRUSH ETERNA PURE BRISTLE EUDAMEDEpredia FDA UDI
- Generic Name
- Microscope slide coverslipper IVD FDA UDI
- Device Name
- ClearVue Coverslipper EUDAMEDClearVue coverslipper- Accessory FDA UDI
- Model / Reference
- P12940 EUDAMEDBrush Eterna Pure Bristle FDA UDI
- Description
- ClearVue coverslipper- Accessory FDA UDI
Identifiers
- Catalog Number
- P12940 FDA UDI
- Primary DI / UDI-DI
- 05051663517706 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL010K3 EUDAMED
- Direct Marketing DI
- 05051663517706 EUDAMED
- FDA Product Code
- KIM FDA UDI
- EMDN Code
- W0202059008 AUTOMATED COVERSLIPPERS EUDAMED
- GMDN Term
- Microscope slide coverslipper IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Brush Eterna Pure Bristle by Shandon Diagnostics Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5051663SDL010K3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
- EUDAMED SRN
- GB-MF-000008187
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (2)
- EUDAMED aa7c3db6-7d69-43ca-9a13-6ea0ee794b05 61 fields · synced Jul 11, 2026
- FDA UDI 59104729-f2d9-4cd7-ba1a-46b17db022ca 34 fields · synced May 30, 2026