OT ~42x42x1 Float K.ges oMR V=200 Superior CE
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- OT ~42x42x1 Float K.ges oMR V=200 Superior CE 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
- 11009903947 EUDAMEDMicroscope slides ~42x42x1 edges chamferd FDA UDI
Identifiers
- Catalog Number
- 11009903947 FDA UDI
- Primary DI / UDI-DI
- 04250317340535 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317302OTONUT EUDAMED
- Unit of Use DI
- 04250317382184 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
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
No
Companion Diagnostics
No
Surgical Instrument
Yes
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
Yes
Manufacturing Date
Yes
Category: General specimen microscopy slide IVD, single-use
OT ~42x42x1 Float K.ges oMR V=200 Superior CE by Paul Marienfeld GmbH & Co. KG — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 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 85e8780b-d652-4e36-bd05-9ec5d349d1b8 61 fields · synced Jul 14, 2026
- FDA UDI 7c88c8fa-6c92-4973-b3dd-448fb94f0e63 33 fields · synced May 30, 2026