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Octotm
EUDAMEDClass IIa (EU MDR)
Ref DSPC-001Model OT304V2I-BModel OT501SIModel OT503V2LNIModel OT501S2LIModel OT504V2LI-BModel OT501S2IModel OT504V2I-BModel OT501IModel OT501LIModel OT504V2I-AModel OT303SI-DModel OT503V2LIModel OT304V2I-AModel OT503V2I
Identity
- Trade Name
- OCTOTM EUDAMED
- Device Name
- OCTOTM EUDAMED
- Model / Reference
- OT304V2I-B EUDAMEDDSPC-001 EUDAMEDOT501SI EUDAMEDOT503V2LNI EUDAMEDOT501S2LI EUDAMEDOT504V2LI-B EUDAMEDOT501S2I EUDAMEDOT504V2I-B EUDAMEDOT501I EUDAMEDOT501LI EUDAMEDOT504V2I-A EUDAMEDOT303SI-D EUDAMEDOT503V2LI EUDAMEDOT304V2I-A EUDAMEDOT503V2I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809294291581 EUDAMED08809294291437 EUDAMED08809294291567 EUDAMED08809294291505 EUDAMED08809294291628 EUDAMED08809294291499 EUDAMED08809294291604 EUDAMED08809294291642 EUDAMED08809294291659 EUDAMED08809294291598 EUDAMED08809294291475 EUDAMED08809294291536 EUDAMED08809294291574 EUDAMED08809294291529 EUDAMED
- Basic UDI-DI
- B-08809294291581 EUDAMEDB-08809294291437 EUDAMEDB-08809294291567 EUDAMEDB-08809294291505 EUDAMEDB-08809294291628 EUDAMEDB-08809294291499 EUDAMEDB-08809294291604 EUDAMEDB-08809294291642 EUDAMEDB-08809294291659 EUDAMEDB-08809294291598 EUDAMEDB-08809294291475 EUDAMEDB-08809294291536 EUDAMEDB-08809294291574 EUDAMEDB-08809294291529 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-08809294291581 | 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 (14)
- EUDAMED 9c093a11-a96a-4620-9085-9ca5f43d2fef 61 fields · synced Oct 7, 2026
- EUDAMED 00be1638-0817-4fe4-a6e8-29c6d3b208a7 61 fields · synced May 11, 2026
- EUDAMED 004f613f-ac0e-41f9-b344-d5a4c14882a7 61 fields · synced May 16, 2026
- EUDAMED bf3ee2ff-0419-4500-8927-5db89b003588 61 fields · synced May 16, 2026
- EUDAMED 9ef3f9e4-8564-443c-b8ec-2cf260465b41 61 fields · synced May 16, 2026
- EUDAMED 720b0992-9d3b-44ef-bc62-67338c0dfe49 61 fields · synced May 17, 2026
- EUDAMED ff3bd47d-245f-4048-9c52-edfaa0716dfc 61 fields · synced May 17, 2026
- EUDAMED 8c9da63e-7a8c-4605-aaf7-4d86fa8fc206 61 fields · synced May 17, 2026
- EUDAMED 269e0412-a131-4577-a72c-dfdefbcead94 61 fields · synced May 17, 2026
- EUDAMED 37d11642-af16-444b-baab-fad39c0e6a2e 61 fields · synced May 18, 2026
- EUDAMED 92b9fba5-1c4e-4ad0-80c7-285d50ed8939 61 fields · synced May 18, 2026
- EUDAMED 855750f5-e9af-4f71-b7d1-3a907803ef32 61 fields · synced May 19, 2026
- EUDAMED e302d0e8-5f17-48e8-baed-211d97d01c1b 61 fields · synced May 19, 2026
- EUDAMED db32e281-8bfc-4616-840b-f749dc8f4512 61 fields · synced May 19, 2026