Identity
- Trade Name
- IlluminOss Reusable Instruments EUDAMED
- Device Name
- Class 1r & 1m Reusable Surgical Instruments EUDAMED
- Model / Reference
- 05-0901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M9860509010 EUDAMED
- Basic UDI-DI
- ++M986SOLIDAWLSCE EUDAMED
- Direct Marketing DI
- +M9860509010F 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
No
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 | ++M986SOLIDAWLSCE | 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 70111687-33b4-45e1-8d02-d20859ac7be1 61 fields · synced Jul 9, 2026