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Rovers® Cervex-brush® Combi
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 380101-030510(k) K043369Ref 380101031
Identity
- Trade Name
- Rovers® Cervex-brush® Combi EUDAMEDFDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Rovers® Cervex-brush® Combi EUDAMEDCervical cell sampler FDA UDI
- Model / Reference
- 380101-030 EUDAMEDFDA UDI380101031 EUDAMED
- Description
- Cervical cell sampler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719189246384 EUDAMEDFDA UDI08719189246360 EUDAMED
- Basic UDI-DI
- 87191892463801010303R EUDAMED87191892463801010313T EUDAMED
- Unit of Use DI
- 08719189246063 EUDAMED
- 510(k) Number
- K043369 FDA UDI
- FDA Product Code
- HHT FDA UDI
- EMDN Code
- A99,U089002 EUDAMEDA99 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 UDIEUDAMED
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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043369 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 87191892463801010303R | Class I | Active |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
- EUDAMED SRN
- NL-MF-000001553
Sources (4)
- EUDAMED 6cb9da25-05d9-4b7a-be86-3a63eb30592a 85 fields · synced Jul 11, 2026
- EUDAMED 29ec5b61-532e-4360-809e-42284a0b9635 61 fields · synced May 18, 2026
- FDA UDI aa2f4d02-b87a-4f9d-9cbb-fc5b2c08cb0a 35 fields · synced May 30, 2026
- FDA 510(k) K043369 1 fields · synced May 18, 2026