Identity
- Trade Name
- IlluminOss Reusable Instruments EUDAMED
- Device Name
- Class IIa Reusable Surgical Instruments EUDAMED
- Model / Reference
- CT-0042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M986CT00420 EUDAMED
- Basic UDI-DI
- ++M986DRILLBITS4K EUDAMED
- Direct Marketing DI
- +M986CT004204 EUDAMED
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
IlluminOss Reusable Instruments by Illuminoss Medical Inc. — Class IIa — 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 | ++M986DRILLBITS4K | Class IIa | Active |
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Manufacturer
- Manufacturer
- IlluminOss Medical
- EUDAMED SRN
- US-MF-000003945
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 09ab1a68-2f46-4b26-a352-3c28fbdbcca7 61 fields · synced Jul 17, 2026