Identity
- Trade Name
- E-type Sterilization Tray EUDAMED
- Device Name
- Sterilization trays EUDAMED
- Model / Reference
- 1600477 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630055505221 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
- France 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
E-type Sterilization Tray 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bien-Air Surgery SA
- EUDAMED SRN
- CH-MF-000016376
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (1)
- EUDAMED 75a7b839-6ff4-4bea-bc4d-ca5602af9b77 61 fields · synced Jul 9, 2026