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Microincision Tip
EUDAMEDClass IIb (EU MDR)
Ref STEE318Model SFT-SRef STEE317Ref STEE322Ref STEE316Ref STEE315Ref STEE327Ref STEE324Ref STEE321Ref STEE303Ref SST-N1Ref STEE306Ref STEE310Ref STEE320Ref STEE308Ref STEE357Ref STEE312
Identity
- Trade Name
- Microincision Tip EUDAMED
- Device Name
- Malleable Tip EUDAMED
- Model / Reference
- SFT-S EUDAMEDSTEE318 EUDAMEDSTEE317 EUDAMEDSTEE322 EUDAMEDSTEE316 EUDAMEDSTEE315 EUDAMEDSTEE327 EUDAMEDSTEE324 EUDAMEDSTEE321 EUDAMEDSTEE303 EUDAMEDSST-N1 EUDAMEDSTEE306 EUDAMEDSTEE310 EUDAMEDSTEE320 EUDAMEDSTEE308 EUDAMEDSTEE357 EUDAMEDSTEE312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810026180484 EUDAMED00810026180477 EUDAMED00810026183966 EUDAMED00810026180460 EUDAMED00810026180453 EUDAMED00810026184017 EUDAMED00810026183980 EUDAMED00810026183959 EUDAMED00810026180330 EUDAMED00810026180231 EUDAMED00810026180361 EUDAMED00810026180408 EUDAMED00810026183942 EUDAMED00810026180385 EUDAMED00810026180590 EUDAMED00810026180422 EUDAMED
- Basic UDI-DI
- 0081002618SFT-SKJ EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
Microincision Tip by Soniquence, LLC — Class IIb — 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 | 0081002618SFT-SKJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (16)
- EUDAMED 8866a7d3-11e7-4d53-a5ce-0e96750ef7c4 61 fields · synced Aug 2, 2026
- EUDAMED e2a4ae4f-442d-4809-9288-fd1cacd0ca3b 61 fields · synced May 16, 2026
- EUDAMED 474338ac-6eee-48fd-a6e4-3b4092da79e6 61 fields · synced May 16, 2026
- EUDAMED b86c5381-090b-4b68-b40e-abcdd601f8d1 61 fields · synced May 16, 2026
- EUDAMED 5c4356f4-9435-4f3e-9d22-031285ab2b9f 61 fields · synced May 17, 2026
- EUDAMED a690f37d-ebda-4a21-bf44-5f623e4de40b 61 fields · synced May 17, 2026
- EUDAMED 7c08fee2-a61d-41a5-ac81-45d2e4a7d786 61 fields · synced May 17, 2026
- EUDAMED 2388ffa1-5877-4352-b355-825ec7b9d291 61 fields · synced May 17, 2026
- EUDAMED e53a376e-1754-4f86-bb77-1062a5b96c38 61 fields · synced May 18, 2026
- EUDAMED c5d848a4-9a92-4f6c-9cfa-851e5fb594e2 61 fields · synced May 18, 2026
- EUDAMED f3f4a226-788c-4209-ba7f-a8cbe15ad812 61 fields · synced May 18, 2026
- EUDAMED e1554192-52e3-4ea5-ba6b-54d0d193ada0 61 fields · synced May 18, 2026
- EUDAMED c21311a3-a04d-41c8-9030-258684fc7314 61 fields · synced May 18, 2026
- EUDAMED 96a4999f-cda6-4e41-a35f-5b97e976c2cb 61 fields · synced May 18, 2026
- EUDAMED 543aeccd-2a24-4b2a-abb3-ffd30751391f 61 fields · synced May 19, 2026
- EUDAMED 14f52ae3-daa0-4c3a-9e13-bd43ceb4424a 61 fields · synced May 19, 2026