Identity
- Trade Name
- PM2 Sterilization Tray Neuro EUDAMED
- Device Name
- Sterilization trays EUDAMED
- Model / Reference
- 1600949 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630055505894 EUDAMED
- Basic UDI-DI
- 76300555_025_FE EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
Classification
- Device Class
- Class I 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
PM2 Sterilization Tray Neuro by Bien-Air Surgery Sa — 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 | 76300555_025_FE | Class I | Active |
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Manufacturer
- Manufacturer
- Bien-Air Surgery SA
- EUDAMED SRN
- CH-MF-000016376
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (1)
- EUDAMED 9ef51bd1-776a-425b-b815-803e4542b209 61 fields · synced Jul 11, 2026