Identity
- Trade Name
- OT 1F 15mm schwarz V=50 Superior EUDAMEDMarienfeld Superior FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- General specimen microscopy slide (IVD) EUDAMED
- Model / Reference
- 1215740 EUDAMEDMicroscope slides 1 fields 15mm black FDA UDI
Identifiers
- Catalog Number
- 1215740 FDA UDI
- Primary DI / UDI-DI
- 04250317337306 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317302OTMSUX EUDAMED
- Unit of Use DI
- 04250317383389 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 1F 15mm schwarz V=50 Superior by Paul Marienfeld GmbH & Co. KG — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen microscopy slide IVD, single-use.
- KT ™ Premium Slides — Slmp, LLC · Class I
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- RANKIN — Yancheng Jingwei Chemicals Co., Ltd · Class I
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- CANCER — Yancheng Jingwei Chemicals Co., Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4250317302OTMSUX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paul Marienfeld GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000023724
Sources (2)
- EUDAMED b8ec2d49-1d9e-4225-a2dd-e0af08730659 61 fields · synced Jun 18, 2026
- FDA UDI 1e8db60f-ec6e-4a2b-9228-8a239133dd51 33 fields · synced May 30, 2026