Identity
- Trade Name
- OT 8F 6mm blau 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
- 1216751 EUDAMEDMicroscope slides 8 fields 6mm blue FDA UDI
Identifiers
- Catalog Number
- 1216751 FDA UDI
- Primary DI / UDI-DI
- 04250317303042 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317302OTMSUX EUDAMED
- Unit of Use DI
- 04250317380920 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 8F 6mm blau V=50 Superior 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 | 4250317302OTMSUX | 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 92331bdd-7a6d-4e0e-98ae-5aff576b6116 61 fields · synced Jul 9, 2026
- FDA UDI b38891eb-7511-4c69-81ff-325fb712f817 33 fields · synced May 30, 2026