Identity
- Trade Name
- DG 15x15 N.1 V=100 STÜ Superior CE EUDAMEDMarienfeld Superior FDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- Microscope slide coverslips (standard thickness) EUDAMED
- Model / Reference
- 0101010 EUDAMED15x15 N.1 FDA UDI
Identifiers
- Catalog Number
- 0101010 FDA UDI
- Primary DI / UDI-DI
- 04250317300133 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317301DGMSQ6 EUDAMED
- Unit of Use DI
- 04250317365668 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 15x15 N.1 V=100 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 | 4250317301DGMSQ6 | 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 739a14bf-0181-4910-993d-a6bdb892a8c4 61 fields · synced Jul 10, 2026
- FDA UDI 7b0b795c-b42c-4805-a561-3da5389e22c8 33 fields · synced May 30, 2026