Identity
- Trade Name
- CELLPRESERV Glass Slide EUDAMEDCELLPRESERV KOLPLAST FDA UDI
- Generic Name
- Cervical cytology microscopy slide IVD FDA UDI
- Device Name
- CELLPRESERV Glass Slide EUDAMED
- Model / Reference
- 400101098 EUDAMEDCELLPRESERV GLASS SLIDE FDA UDI
Identifiers
- Catalog Number
- 400101098 FDA UDI
- Primary DI / UDI-DI
- 07898027905490 EUDAMEDFDA UDI
- Basic UDI-DI
- 789802790CGSW4 EUDAMED
- Direct Marketing DI
- 07898027905490 EUDAMED
- FDA Product Code
- KEW FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Cervical cytology microscopy slide 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cervical cytology microscopy slide IVD
Cellpreserv Kolplast by Kolplast CI SA — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 f7df79cb-cd03-4e3f-b7bb-bca3c0b07514 33 fields · synced Jun 18, 2026
- EUDAMED fb40c2f7-58f4-4c81-b591-a6180bf62e1a 61 fields · synced Jun 18, 2026