Identity
- Trade Name
- OCTOTM EUDAMED
- Device Name
- OCTOTM EUDAMED
- Model / Reference
- OT301I EUDAMEDDSPC-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809294291635 EUDAMED
- Basic UDI-DI
- B-08809294291635 EUDAMED
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Octotm by DalimsurgNET corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809294291635 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DalimsurgNET corporation
- EUDAMED SRN
- KR-MF-000014570
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 5d74445d-424f-4f31-a3b7-88993c9b20d5 61 fields · synced Jun 19, 2026