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OT ~76x45x1 Float ubk 2xMR20 V=50 Stü Superior
EUDAMEDFDA UDIClass A (EU MDR)
Ref 110029091
Identity
- Trade Name
- OT ~76x45x1 Float ubk 2xMR20 V=50 Stü Superior EUDAMEDMarienfeld Superior FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- Special size microscopy Slides (IVD) EUDAMED
- Model / Reference
- 110029091 EUDAMEDMicroscope slides ~76x45x1 cut edges 2xmarking area 20mm FDA UDI
Identifiers
- Catalog Number
- 110029091 FDA UDI
- Primary DI / UDI-DI
- 04250317363008 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317302OTONUT EUDAMED
- Unit of Use DI
- 04250317386137 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
- 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
OT ~76x45x1 Float ubk 2xMR20 V=50 Stü Superior by Paul Marienfeld GmbH & Co. KG — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4250317302OTONUT | 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 76d01ba2-207a-4358-a190-149345995ab9 61 fields · synced Jun 18, 2026
- FDA UDI 8843df51-6e74-4c1d-af10-104728912c9f 33 fields · synced May 30, 2026