Identity
- Trade Name
- IlluminOss Reusable Instruments EUDAMED
- Device Name
- Class 1r & 1m Reusable Surgical Instruments EUDAMED
- Model / Reference
- CT-0235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M986CT02350 EUDAMED
- Basic UDI-DI
- ++M986RULERMG EUDAMED
- Direct Marketing DI
- +M986CT023508 EUDAMED
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IlluminOss Reusable Instruments by Illuminoss Medical Inc. — 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 | ++M986RULERMG | Class I | 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 861e2ddb-8853-4c78-9981-858b2d4ad98f 61 fields · synced Sep 17, 2026