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Scanner Tip (S x 2pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6583225Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1Ref ST6583225Ref 91015Ref 91013Ref 6583211
Identity
- Trade Name
- Scanner Tip (S x 2pcs) EUDAMEDNeoScan™ 2000 Tip S (2pcs) EUDAMEDNeoScan™ 1000 Tip S (2pcs EUDAMEDNeoScan FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMEDIntraoral scanner S tip 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 EUDAMED6583225 EUDAMEDST6583225 EUDAMED91015 EUDAMED91013 EUDAMED6583211 EUDAMEDTP103N FDA UDI
- Description
- Intraoral scanner S tip FDA UDI
Identifiers
- Catalog Number
- 91013 FDA UDI
- Primary DI / UDI-DI
- 26973993441045 EUDAMED06973993441065 EUDAMEDFDA UDI06973993441560 EUDAMED06973993441300 EUDAMED06973993441027 EUDAMED
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- Direct Marketing DI
- 06973993441300 EUDAMED06973993441065 EUDAMED06973993441027 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 EUDAMEDGermany EUDAMEDItaly 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Scanner Tip (S x 2pcs) 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 (7)
- EUDAMED d7c3511a-4747-473b-9185-fa97ea0c3e72 61 fields · synced Aug 1, 2026
- FDA UDI ed664de4-7cf1-4586-8de1-390ad0757deb 34 fields · synced May 30, 2026
- EUDAMED 2bf2860c-acb1-461c-b031-7a47eef0307c 61 fields · synced Jun 11, 2026
- EUDAMED 61270f3f-e36a-4865-934e-4b4733aa1825 61 fields · synced Jul 14, 2026
- EUDAMED f1613f32-863a-4eb3-a5c4-d69147c9e488 61 fields · synced Jul 15, 2026
- EUDAMED a366d34b-5b51-4ea8-a81d-99e7b94e220c 61 fields · synced Jul 17, 2026
- EUDAMED 49b1bcbe-ce52-46bb-8b19-ed80430d21ef 61 fields · synced Aug 1, 2026