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FemBloc Permanent Birth Control
EUDAMEDClass I (EU MDR)
Ref FDS-200
by Femasys Inc.
Identity
- Trade Name
- FemBloc Permanent Birth Control EUDAMED
- Device Name
- FemBloc Permanent Birth Control EUDAMED
- Model / Reference
- FDS-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30859500005227 EUDAMED
- Basic UDI-DI
- 00859500005FDSNP EUDAMED
- Unit of Use DI
- 00859500005226 EUDAMED
- EMDN Code
- U110299 DEVICES FOR FEMALE CONTRACEPTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
FemBloc Permanent Birth Control by Femasys Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00859500005FDSNP | Class I | Active |
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Manufacturer
- Manufacturer
- Femasys Inc.
- EUDAMED SRN
- US-MF-000009888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ac4a83aa-e214-4b85-afe6-150c708e6cbf 61 fields · synced Jun 20, 2026