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Para-Pak® CON-Trate® Concentration System - 200

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 960200

by Meridian Bioscience Inc.

Identity

Trade Name
Para-Pak® CON-Trate® Concentration System - 200 EUDAMED
Para-Pak CON-Trate FDA UDI
Generic Name
Faecal parasite isolation kit IVD FDA UDI
Device Name
Para-Pak® CON-Trate® Concentration System - 200 EUDAMED
The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae and protozoan cysts from feces. FDA UDI
Model / Reference
960200 EUDAMEDFDA UDI
Description
The Meridian CON-Trate System is a complete system for concentrating and recovering helminth eggs, larvae and protozoan cysts from feces. FDA UDI

Identifiers

Catalog Number
960200 FDA UDI
Primary DI / UDI-DI
00840733102721 EUDAMEDFDA UDI
Basic UDI-DI
008407331PARAPAKCLA013ZA EUDAMED
Direct Marketing DI
00840733102721 EUDAMED
FDA Product Code
LKS FDA UDI
EMDN Code
W0104050101 PARASITOLOGY EXTRACTION REAGENTS EUDAMED
GMDN Term
Faecal parasite isolation kit IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
866.2900 FDA UDI
Market of Registration
Italy 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

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Para-Pak® CON-Trate® Concentration System - 200 by Meridian Bioscience Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience Inc.
EUDAMED SRN
US-MF-000044096
Authorised Representative
Meridian Bioscience Europe S.r.l. IT-AR-000010460

Sources (2)

  • EUDAMED 4a45c65f-9709-4423-b9ed-9c399dfd7720 61 fields · synced Jun 19, 2026
  • FDA UDI 3df3b671-fac0-4093-b73f-53a8f60440bf 36 fields · synced May 30, 2026