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Nautilus™ Intrasaccular System
EUDAMEDClass III (EU MDR)
Ref PRN 150-04Ref PRN 150-05Ref PRN 150-07
Identity
- Trade Name
- Nautilus™ Intrasaccular System EUDAMED
- Device Name
- Nautilus Intrasaccular System EUDAMED
- Model / Reference
- PRN 150-04 EUDAMEDPRN 150-05 EUDAMEDPRN 150-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290018880012 EUDAMED07290018880029 EUDAMED07290018880043 EUDAMED
- Basic UDI-DI
- 7290018880PRN1509Q EUDAMED
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
Category: Fixture/appliance dental drill bit, reusable
Nautilus™ Intrasaccular System by EndoStream Medical Ltd — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
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- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
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 | 7290018880PRN1509Q | Class III | Active |
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Manufacturer
- Manufacturer
- EndoStream Medical Ltd
- EUDAMED SRN
- IL-MF-000012179
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (3)
- EUDAMED c353252a-652c-4470-976c-3325d98f4cff 61 fields · synced Aug 3, 2026
- EUDAMED 358fc492-3e39-4ee7-be6b-81811708249a 61 fields · synced May 17, 2026
- EUDAMED b1385937-63d4-482f-afa0-4226ec6a775d 61 fields · synced May 18, 2026