Straumann SIRIOS X3
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Straumann SIRIOS™ X3 Intraoral scanner Charging Holder EUDAMEDStraumann SIRIOS X3 FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMEDStraumann SIRIOS™ X3 Intraoral scanner Charging Holder FDA UDI
- Model / Reference
- AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1 EUDAMEDSTS-6583526 EUDAMEDCHR 300E FDA UDI
- Description
- Straumann SIRIOS™ X3 Intraoral scanner Charging Holder FDA UDI
Identifiers
- Catalog Number
- STS-6583526 FDA UDI
- Primary DI / UDI-DI
- 06973993441751 EUDAMEDFDA UDI
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Intraoral optical scanning system
Straumann SIRIOS X3 by Alliedstar Medical Equipment Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alliedstar Medical Equipment Co., Ltd.
Sources (2)
- FDA UDI b7e0b039-8a75-4c6b-bde6-b3b9586f297f 34 fields · synced Jul 12, 2026
- EUDAMED 6dec80f3-87df-4cf1-8fa6-186685ea395a 61 fields · synced Jul 12, 2026