Cover Slips
by New Erie Scientific LLC 239 variants
Ref BC05000760A140MNZ0
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number081004133NES002MQ 00810041333308 | Date21 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810041333308 | Date17 Mar 2025 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Cover Slips EUDAMEDEpredia GUDID
- Generic Name
- Microscope slide coverslip IVD
- Device Name
- Microscope Slide Coverslips
- Model / Reference
- BC05000760A140MNZ0
- Primary DI / UDI-DI
- 00810041333308
- Basic UDI-DI
- 081004133NES002MQ
- Unit of Use DI
- 10810041333305
- FDA Product Code
- KES
- EMDN Code
- W0503900202 Microscope slides coverslip
- GMDN Term
- Microscope slide coverslip IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 864.3010
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000008165
- Authorised representative
- Epredia Netherlands B.V. NL-AR-000001488
Other devices from New Erie Scientific LLC
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: 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