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Non-Adhesion Microscope Slide
EUDAMEDFDA UDIClass A (EU MDR)
Ref AA00000112E01MNZ11
Identity
- Trade Name
- Non-Adhesion Microscope Slide EUDAMEDEpredia FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- Microscope Slides EUDAMED
- Model / Reference
- AA00000112E01MNZ11 EUDAMEDMicroscope Slide Non Adhesion FDA UDI
Identifiers
- Catalog Number
- AA00000112E01MNZ11 FDA UDI
- Primary DI / UDI-DI
- 00810041334121 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004133NES001MN EUDAMED
- Unit of Use DI
- 10810041334128 EUDAMED
- FDA Product Code
- KEW FDA UDI
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
- GMDN Term
- General specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Non-Adhesion Microscope Slide by New Erie Scientific LLC — 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 | 081004133NES001MN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- New Erie Scientific LLC
- EUDAMED SRN
- US-MF-000008165
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (2)
- EUDAMED a793b3dc-b4e0-4dcd-901a-8817b251cc19 61 fields · synced Jun 19, 2026
- FDA UDI 86eded9c-c522-40d7-85fd-a33262cfa0e6 33 fields · synced May 29, 2026