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Straumann® Mini Implant
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 042.944S510(k) K191895
Identity
- Device Name
- Straumann® Mini Implant EUDAMED
- Model / Reference
- 042.944S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630031738837 EUDAMED
- Basic UDI-DI
- 0763003170109QR EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Straumann® Mini Implant by Institut Straumann AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191895 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0763003170109QR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (2)
- EUDAMED 7a95c79e-3c0f-46ac-8486-4b7fb729ad1d 85 fields · synced Jun 18, 2026
- FDA 510(k) K191895 1 fields · synced May 18, 2026