Identity
- Trade Name
- CELLPRESERV Filter EUDAMEDCELLPRESERV KOLPLAST FDA UDI
- Generic Name
- Microfilter imaging plate IVD FDA UDI
- Device Name
- CELLPRESERV Filter EUDAMED
- Model / Reference
- 10.1347 EUDAMEDFILTRO GIN CELLPRESERV FDA UDI
Identifiers
- Catalog Number
- 10.1347 FDA UDI
- Primary DI / UDI-DI
- 07898027900792 EUDAMEDFDA UDI
- Basic UDI-DI
- 789802790CF4R EUDAMED
- Direct Marketing DI
- 07898027900792 EUDAMED
- FDA Product Code
- KET FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Microfilter imaging plate IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Portugal 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microfilter imaging plate IVD
Cellpreserv Kolplast by Kolplast CI SA — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kolplast CI SA
Sources (2)
- FDA UDI 9bbfa1fe-3645-4d54-85bc-c76de108f2b9 33 fields · synced Jul 11, 2026
- EUDAMED 7cbc4ef6-69e3-48d6-8a93-bc84c487fbf0 61 fields · synced Jul 11, 2026