Identity
- Trade Name
- SPATOLA DI AYRE EUDAMED
- Device Name
- ENDOBRUSH EUDAMED
- Model / Reference
- SPA1 N100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18056977352184 EUDAMED
- Basic UDI-DI
- 805697735000JG EUDAMED
- Direct Marketing DI
- 18056977352184 EUDAMED
- EMDN Code
- U089002 DEVICES FOR GYNAECOLOGICAL CYTOLOGY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Spatola Di Ayre by Biogyn Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Spatola Ayre in plastica
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 | 805697735000JG | Class I | Active |
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Manufacturer
- Manufacturer
- Biogyn Srl
- EUDAMED SRN
- IT-MF-000033403
Sources (1)
- EUDAMED 2dab80a1-d0c0-46ba-ba23-992089ebff36 61 fields · synced Jun 18, 2026