Identity
- Trade Name
- Globe Scientific FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- Non Adhesive Microscope Slides EUDAMEDMicroscope Slides, Diamond Essentials, Glass, Frosted: 1 End, 1 Side, Safety Corners, Moisture Proof Packaging, 72/box, 20 boxes/carton FDA UDI
- Model / Reference
- 1294 EUDAMEDFDA UDI
- Description
- Microscope Slides, Diamond Essentials, Glass, Frosted: 1 End, 1 Side, Safety Corners, Moisture Proof Packaging, 72/box, 20 boxes/carton FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095617956 EUDAMEDFDA UDI
- Basic UDI-DI
- 8721398269NADSCX EUDAMED
- Direct Marketing DI
- 00840095617956 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
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
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General specimen microscopy slide IVD, single-use
Non Adhesive Microscope Slides by Globe Scientific Europe B.V. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8721398269NADSCX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Globe Scientific Europe B.V.
- EUDAMED SRN
- NL-MF-000046521
Sources (2)
- EUDAMED 0a2dcebf-fb8e-4ec1-8a89-dccf86e789a3 61 fields · synced Jun 19, 2026
- FDA UDI 08ada676-f103-4298-9d2b-29e8efebd31a 33 fields · synced May 30, 2026