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Sterilization tray, for ActivaScrew™ Cannulated instruments
EUDAMEDClass I (EU MDR)
Ref B-ISC-9000
Identity
- Trade Name
- Sterilization tray, for ActivaScrew™ Cannulated instruments EUDAMEDActiva Instrument EUDAMED
- Device Name
- Sterilization Tray EUDAMEDSterilization tray, for ActivaScrew™ Cannulated instruments EUDAMED
- Model / Reference
- B-ISC-9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394005679 EUDAMED
- Basic UDI-DI
- 6438394INS015WR EUDAMEDB-06438394005679 EUDAMED
- Direct Marketing DI
- 06438394005679 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Instrument tray, reusable
Sterilization tray, for ActivaScrew™ Cannulated instruments by Bioretec Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438394INS015WR | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS015WR | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 76106552-1eff-4976-964a-23650954d36c 61 fields · synced Jul 14, 2026
- EUDAMED e8a61ed9-e544-4b9f-839b-b2fe70d3994f 61 fields · synced May 17, 2026