Identity
- Trade Name
- Rovers® Cervex-brush® Combi EUDAMEDRovers® Cervex-Brush® Combi RT FDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Rovers® Cervex-brush® Combi EUDAMEDCervical cell sampler FDA UDI
- Model / Reference
- 380301000 EUDAMEDFDA UDI
- Description
- Cervical cell sampler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719189246186 EUDAMEDFDA UDI
- Basic UDI-DI
- 87191892463803010004A EUDAMED
- Unit of Use DI
- 08719189246209 EUDAMED
- 510(k) Number
- K043369 FDA UDI
- FDA Product Code
- HHT FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Cytology scraper, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
Yes
FDA UDI
Rovers® Cervex-brush® Combi by Rovers Medical Devices B.V. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 87191892463803010004A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
- EUDAMED SRN
- NL-MF-000001553
Sources (2)
- EUDAMED 673f9eaf-6bbf-4fef-ad2d-d10d2afc4014 61 fields · synced Jul 12, 2026
- FDA UDI 93f1694e-7362-4f90-9b12-36ed0aa32c51 35 fields · synced May 29, 2026