Identity
- Trade Name
- Kova Plastics FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- KOVA Plastics Urinalysis System EUDAMEDBox containing 100 Kova Slide II with grids (plastic 4-chambered microscope slides with gridlines for urinalysis) FDA UDI
- Model / Reference
- 87100E EUDAMEDKOVASLIDEIIw/GRID FDA UDI
- Description
- Box containing 100 Kova Slide II with grids (plastic 4-chambered microscope slides with gridlines for urinalysis) FDA UDI
Identifiers
- Catalog Number
- 87100 / 87100E FDA UDI
- Primary DI / UDI-DI
- 00850033297065 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850033297KOVAPLASTICSF5 EUDAMED
- Direct Marketing DI
- 00850033297065 EUDAMED
- FDA Product Code
- KEW FDA UDI
- EMDN Code
- W0503900202 MICROSCOPE SLIDES COVERSLIP EUDAMED
- GMDN Term
- General specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
KOVA Plastics Urinalysis System by Alltrista Plastics LLC — 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 | 0850033297KOVAPLASTICSF5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Alltrista Plastics LLC
- EUDAMED SRN
- US-MF-000021674
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 1a20c90e-aa83-4886-86ed-1971113b8cde 61 fields · synced Jul 8, 2026
- FDA UDI adb20010-6a07-4595-80f2-17b5ab161219 36 fields · synced May 30, 2026