Identity
- Trade Name
- Para-Pak EcoFix EUDAMEDPara-Pak FDA UDI
- Generic Name
- Faecal specimen container IVD, transport buffer/medium FDA UDI
- Device Name
- Para-Pak EcoFix EUDAMEDPara-Pak EcoFix is a convenient one-vial system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimens. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. Primary DI Number 00840733102066 indicates the outer case of the device. FDA UDI
- Model / Reference
- 901312 EUDAMEDFDA UDI
- Description
- Para-Pak EcoFix is a convenient one-vial system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimens. The fixative affords an excellent means of minimizing the adverse effects of delay in specimen transport. Primary DI Number 00840733102066 indicates the outer case of the device. FDA UDI
Identifiers
- Catalog Number
- 901312 FDA UDI
- Primary DI / UDI-DI
- 00840733102066 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA005ZB EUDAMED
- Direct Marketing DI
- 00840733102066 EUDAMED
- FDA Product Code
- LDX FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Faecal specimen container IVD, transport buffer/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
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
No
FDA UDI
Para-Pak EcoFix 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 | 008407331PARAPAKCLA005ZB | 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 52fad2e7-c40f-4e63-b4d9-2efc3fc4672f 61 fields · synced Jul 9, 2026
- FDA UDI c2909d35-118e-4613-b71d-35876bd324eb 36 fields · synced May 30, 2026