Identity
- Trade Name
- Para-Pak® Clean Vial EUDAMEDPara-Pak CLEAN FDA UDI
- Generic Name
- Faecal specimen container IVD, no additive FDA UDI
- Device Name
- Para-Pak® Clean Vial EUDAMEDDevice for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites. FDA UDI
- Model / Reference
- 900312 EUDAMEDFDA UDI
- Description
- Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites. FDA UDI
Identifiers
- Catalog Number
- 900312 FDA UDI
- Primary DI / UDI-DI
- 00840733102691 EUDAMEDFDA UDI
- Basic UDI-DI
- 008407331PARAPAKCLA004Z9 EUDAMED
- Direct Marketing DI
- 00840733102691 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
- GMDN Term
- Faecal specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 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
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® Clean Vial 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 | 008407331PARAPAKCLA004Z9 | 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 347bb0c2-d81b-4028-8ed8-59ccee73cbe3 61 fields · synced Jul 9, 2026
- FDA UDI 76823485-66a5-4168-ae88-56493eda8b5f 35 fields · synced May 29, 2026