Identity
- Trade Name
- DG 5 D N.3 V=50 STÜ Superior CE EUDAMEDMarienfeld Superior FDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- Microscope slide coverslips (special thickness) EUDAMED
- Model / Reference
- 0114450 EUDAMED5 N.3 FDA UDI
Identifiers
- Catalog Number
- 0114450 FDA UDI
- Primary DI / UDI-DI
- 04064279009528 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317301DGONQ2 EUDAMED
- Unit of Use DI
- 04064279014591 EUDAMED
- FDA Product Code
- KES FDA UDI
- EMDN Code
- W0503900202 MICROSCOPE SLIDES COVERSLIP EUDAMED
- GMDN Term
- Microscope slide coverslip IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Germany 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
No
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
DG 5 D N.3 V=50 STÜ Superior CE by Paul Marienfeld GmbH & Co. KG — 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 | 4250317301DGONQ2 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Paul Marienfeld GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000023724
Sources (2)
- EUDAMED 3d51b971-f610-4c16-bdd1-472f5353bdef 61 fields · synced Jun 18, 2026
- FDA UDI ec9d2530-9383-4c37-b562-18bdb05f476d 33 fields · synced May 29, 2026