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Alliedstar Sensa
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6583319Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1
Identity
- Trade Name
- Alliedstar Sensa EUDAMEDFDA UDIAlliedstar Sensa Charging Holder EUDAMED
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMED
- 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 EUDAMED6583319 EUDAMEDCHR 300W FDA UDI
Identifiers
- Catalog Number
- 6583319 FDA UDI
- Primary DI / UDI-DI
- 06973993441645 EUDAMEDFDA UDI
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- Direct Marketing DI
- 06973993441645 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
- Hungary EUDAMEDRomania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alliedstar Sensa by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697399344alliedstar01SL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alliedstar Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008845
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (3)
- EUDAMED d50d80fa-f38d-4d94-81fd-f34accdf8704 61 fields · synced Jul 9, 2026
- FDA UDI fd67a67a-c3f4-4244-8138-25e37124285f 33 fields · synced May 30, 2026
- EUDAMED a363f608-d318-40c5-9b49-8722c815bc8b 61 fields · synced Jul 9, 2026