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OT 75x25x1 Float fbk oMR V=50 Superior

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 1000412

by Paul Marienfeld GmbH & Co. KG

Identity

Trade Name
OT 75x25x1 Float fbk oMR V=50 Superior EUDAMED
Marienfeld Superior FDA UDI
Generic Name
General specimen microscopy slide IVD, single-use FDA UDI
Device Name
General specimen microscopy slide (IVD) EUDAMED
Model / Reference
1000412 EUDAMED
Microscope slides 75x25x1 ground edges FDA UDI

Identifiers

Catalog Number
1000412 FDA UDI
Primary DI / UDI-DI
04250317302120 EUDAMEDFDA UDI
Basic UDI-DI
4250317302OTMSUX EUDAMED
Unit of Use DI
04250317380326 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 EUDAMED
Class 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 75x25x1 Float fbk oMR 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

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Manufacturer

Manufacturer
Paul Marienfeld GmbH & Co. KG
EUDAMED SRN
DE-MF-000023724

Sources (2)

  • EUDAMED 5f6cfeaa-cdb3-434c-a7de-c10e1f6d96ba 61 fields · synced Oct 6, 2026
  • FDA UDI 6df6f13c-34f4-4f62-ac9f-46957e49022e 33 fields · synced May 29, 2026