Identity
- Trade Name
- HIDRAFEM EUDAMED
- Device Name
- HIDRAFEM EUDAMED
- Model / Reference
- MC04-01 EUDAMED13001813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055267242887 EUDAMED
- Basic UDI-DI
- 80336618006030100000000SY EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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
Hidrafem by Fidia Farmaceutici S.p.A. — Class IIb — 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 | 80336618006030100000000SY | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED 4cdf6d6c-e61b-4b8b-8b4e-3617efda77da 61 fields · synced Jul 17, 2026