Identity
- Trade Name
- Rovers® Evalyn® Brush EUDAMEDFDA UDI
- Generic Name
- Cytology scraper, single-use FDA UDI
- Device Name
- Rovers® Evalyn® Brush EUDAMEDThe Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe and effective collection of cell material from the vagina. FDA UDI
- Model / Reference
- 380500150 EUDAMEDFDA UDI
- Description
- The Evalyn® Brush Is a single use (self) cell-sampler device that allows easy, painless, safe and effective collection of cell material from the vagina. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719189246445 EUDAMEDFDA UDI
- Basic UDI-DI
- 87191892463805001505H EUDAMED
- 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
Yes
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
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
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® Evalyn® Brush 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 | 87191892463805001505H | 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 838cf53d-b131-4312-8bad-666f16628b6f 61 fields · synced Jul 9, 2026
- FDA UDI c48a308d-41cb-4e71-a3c8-8abaca4f2fd8 33 fields · synced May 30, 2026