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ASP Device

EUDAMEDFDA UDI

Class A (EU MDR)

Ref PI-0076558

by ASP Health Inc.

Identity

Trade Name
ASP Device EUDAMED
ASP Device; ASP System; ROSE Prep pro FDA UDI
Generic Name
Microscope slide stainer IVD FDA UDI
Device Name
ASP System EUDAMED
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens. FDA UDI
Model / Reference
PI-0076558 EUDAMED
REV P FDA UDI
Description
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens. FDA UDI

Identifiers

Catalog Number
PI-0076558 FDA UDI
Primary DI / UDI-DI
00860008222404 EUDAMEDFDA UDI
Basic UDI-DI
08600082224ASPMK EUDAMED
FDA Product Code
KPA FDA UDI
EMDN Code
W0202059002,W0202059085 EUDAMED
GMDN Term
Microscope slide stainer IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
864.3800 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

Yes

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

ASP Device by ASP Health Inc. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ASP Health Inc.
EUDAMED SRN
US-MF-000038725
Authorised Representative
CEpartner4U NL-AR-000000111

Sources (2)

  • EUDAMED f62ba3d4-00fd-4804-8b07-588ef8202d9c 61 fields · synced Jul 9, 2026
  • FDA UDI 1e57d8d3-ccc6-4054-8a30-5bd8c7e6b562 36 fields · synced May 30, 2026