Identity
- Device Name
- Sterilization tray EUDAMED
- Model / Reference
- 09-0028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760305400215 EUDAMED
- Basic UDI-DI
- 37603054003STBSM EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The Sterilization Tray is used during the sterilization cycle of reusable instruments manufactured by Quantum Surgical to prevent any damage. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Instrument tray, reusable
Sterilization tray by Quantum Surgical SAS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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 | 37603054003STBSM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantum Surgical sas
- EUDAMED SRN
- FR-PR-000041795
Sources (1)
- EUDAMED 1927ec2e-e760-4258-bf6d-b9efa0946dd4 61 fields · synced Jun 17, 2026