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FemCerv Endocervical Sampler
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FCV-013
by Femasys Inc.
Identity
- Trade Name
- FemCerv Endocervical Sampler EUDAMEDFemCerv FDA UDI
- Generic Name
- Cervical cytology brush FDA UDI
- Device Name
- FemCerv Endocervical Sampler EUDAMEDFemCerv, Endocervical Sampler, 13 Fr, 10-pack FDA UDI
- Model / Reference
- FCV-013 EUDAMEDFDA UDI
- Description
- FemCerv, Endocervical Sampler, 13 Fr, 10-pack FDA UDI
Identifiers
- Catalog Number
- 03142 FDA UDI
- Primary DI / UDI-DI
- 30859500005050 EUDAMEDFDA UDI
- Basic UDI-DI
- 00859500005FCVNS EUDAMED
- 510(k) Number
- K122658 FDA UDI
- FDA Product Code
- PCF FDA UDI
- EMDN Code
- U089010 UTERINE CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Cervical cytology brush FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1050 FDA UDI
- Market of Registration
- Spain 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
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
FemCerv Endocervical Sampler by Femasys Inc. — Class IIa — 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 | 00859500005FCVNS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Femasys Inc.
- EUDAMED SRN
- US-MF-000009888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 513c1469-973b-4489-97b1-8ede78ab57ea 61 fields · synced Aug 4, 2026
- FDA UDI 14be2f3d-d2d5-45de-936a-8bf6b6ccb4e8 35 fields · synced May 30, 2026