Microscope Slide Coverslips
by New Erie Scientific LLC EUDAMEDGUDID
Active
Ref BC02400730A140MNZ0
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00810041333148 | Date17 Mar 2025 | StatusListed |
| European Union | CE/IVDR EUDAMED | Number081004133NES002MQ | Date5 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Microscope Slide Coverslips EUDAMEDEpredia GUDID
- Generic Name
- Microscope slide coverslip IVD
- Model / Ref / Catalog
- BC02400730A140MNZ0, Cover Glass
- Primary DI / UDI-DI
- 00810041333148
- Basic UDI-DI
- 081004133NES002MQ
- Unit of Use DI
- 10810041333145
- 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
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | BC02400730A140MNZ0 | Cover Glass |
| 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 (18)
- Sterile: 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