Identity
- Trade Name
- Para-Pak® CON-Trate® Tubes & Caps EUDAMEDCON-Trate Bulk Tubes & Caps FDA UDI
- Generic Name
- Faecal parasite isolation kit IVD FDA UDI
- Device Name
- Para-Pak® CON-Trate® Tubes & Caps EUDAMEDThe Meridian CON-Trate system is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces. FDA UDI
- Model / Reference
- 800400 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
- 800400 FDA UDI
- Primary DI / UDI-DI
- 00840733102592 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA015ZE EUDAMED
- Direct Marketing DI
- 00840733102592 EUDAMED
- FDA Product Code
- LKS FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Faecal parasite isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass 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
No
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® Tubes & Caps by Meridian Bioscience 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008407331PARAPAKCLA015ZE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 7c89c25d-9c2a-4d3b-a9d4-b1eee9271f7e 61 fields · synced Jun 19, 2026
- FDA UDI 5aad369a-61da-43a7-b0eb-1353a9814719 36 fields · synced May 29, 2026