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Implant Surgery System Sweden & Martina
EUDAMEDClass IIa (EU MDR)
Ref AEU-6000SWM
Identity
- Device Name
- IMPLANT SURGERY SYSTEM SWEDEN & MARTINA EUDAMED
- Model / Reference
- AEU-6000SWM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10817417021187 EUDAMED
- Basic UDI-DI
- B-10817417021187 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Implant Surgery System Sweden & Martina by Aseptico, Inc. — 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-10817417021187 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 873f5c31-962a-4dcc-b3fd-054738493c00 61 fields · synced Jul 23, 2026