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Rovers® EndoCervex-Brush®
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 380100703
Identity
- Trade Name
- Rovers® EndoCervex-Brush® EUDAMEDFDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Rovers® EndoCervex-Brush® EUDAMEDEndoCervical cell sampler FDA UDI
- Model / Reference
- 380100703 EUDAMEDFDA UDI
- Description
- EndoCervical cell sampler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719189246100 EUDAMEDFDA UDI
- Basic UDI-DI
- 87191892463801007034J EUDAMED
- Unit of Use DI
- 08719189246094 EUDAMED
- 510(k) Number
- K001119 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
No
FDA UDI
Rovers® EndoCervex-Brush® 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 | K001119 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 87191892463801007034J | Class I | Active |
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Manufacturer
- Manufacturer
- Rovers Medical Devices B.V.
- EUDAMED SRN
- NL-MF-000001553
Sources (3)
- EUDAMED 83941b02-e099-4ba9-ae63-9cab6a98e180 61 fields · synced Jul 27, 2026
- FDA UDI 4bbbdafb-f2bb-47da-9ea5-0f56ca88a7c8 35 fields · synced May 26, 2026
- FDA 510(k) K001119 1 fields · synced May 18, 2026