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Intraoral Scanner
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6583382Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1Ref 6583624Ref 6583169Ref 6583567Ref ST6583380Ref ST6583386Ref 6583501Ref 6583380Ref 6583368Ref 91000Ref 6583386Ref 91001Ref ST6583202Ref ST6583202HRef 6583384Ref 6583207
Identity
- Trade Name
- Intraoral Scanner EUDAMEDNeoScan™ 2000 Intraoral Scanner EUDAMEDNeoScan FDA UDINeoss FDA UDIStraumann Sirios FDA UDIAlliedStar FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMEDFDA UDINeoScan 1000 Intraoral Scanner FDA UDIAS 100 Intraoral Scanner 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 EUDAMED6583382 EUDAMED6583624 EUDAMED6583169 EUDAMED6583567 EUDAMEDST6583380 EUDAMEDST6583386 EUDAMED6583501 EUDAMED6583380 EUDAMED6583368 EUDAMED91000 EUDAMED6583386 EUDAMED91001 EUDAMEDST6583202 EUDAMEDST6583202H EUDAMED6583384 EUDAMED6583207 EUDAMEDNeoScan 1000 FDA UDINeoScan 2000 FDA UDIST 200E FDA UDIAS 100 FDA UDI
- Description
- NeoScan 1000 Intraoral Scanner FDA UDIIntraoral Scanner FDA UDIAS 100 Intraoral Scanner FDA UDI
Identifiers
- Catalog Number
- 91000 FDA UDI91001 FDA UDI6583169 FDA UDI
- Primary DI / UDI-DI
- 06973993442826 EUDAMED06973993442031 EUDAMEDFDA UDI06973993442086 EUDAMEDFDA UDI06973993442222 EUDAMEDFDA UDI06973993442017 EUDAMEDFDA UDI06973993442673 EUDAMED06973993442581 EUDAMED06973993442239 EUDAMED06973993442246 EUDAMED06973993442475 EUDAMED06973993442307 EUDAMED06973993442185 EUDAMED06973993442314 EUDAMED06973993442499 EUDAMED06973993442352 EUDAMED06973993442796 EUDAMED
- 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
- Hungary EUDAMEDItaly EUDAMEDFrance EUDAMEDAustria EUDAMEDGermany EUDAMEDTürkiye EUDAMEDBulgaria 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 UDIFDA 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
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Intraoral Scanner by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 (21)
- EUDAMED a2fcc528-f771-4999-926f-e01afd4af4e2 61 fields · synced Aug 4, 2026
- FDA UDI 51c43355-efec-499d-8ef4-f3b521becb07 35 fields · synced May 30, 2026
- FDA UDI 76116538-7c32-4f01-9e57-e703bbad48ee 35 fields · synced May 30, 2026
- FDA UDI bb60d7a4-cc76-47cf-ab62-23375b3ed659 34 fields · synced May 30, 2026
- FDA UDI 66141e4f-3d2c-4a58-89ae-e8655409a2cf 35 fields · synced May 30, 2026
- EUDAMED 1026aa21-91bd-4512-b3fb-1709e647e2df 61 fields · synced Jun 18, 2026
- EUDAMED 75928e2d-c799-48e7-bae2-9f89ea18257d 61 fields · synced Jul 9, 2026
- EUDAMED b74fdaf0-2aff-4a14-9902-2b6e8ff19976 61 fields · synced Jul 9, 2026
- EUDAMED 6ea6dd39-a9b1-4d03-84cf-3b8af5ff4f32 61 fields · synced Jul 12, 2026
- EUDAMED 09cc3b97-5972-49b3-87c5-f7eb0fe76bb9 61 fields · synced Jul 12, 2026
- EUDAMED f230ddc1-9e23-49db-bb78-373716992231 61 fields · synced Jul 12, 2026
- EUDAMED 6bd8f54c-0a24-4c15-bff3-895584f50b3d 61 fields · synced Jul 13, 2026
- EUDAMED cd32222a-86e8-46a0-8211-831cdb34665d 61 fields · synced Jul 14, 2026
- EUDAMED 05173588-c65d-4535-9c5b-af09c90e4bea 61 fields · synced Jul 15, 2026
- EUDAMED 85ba6d38-5e6a-400d-a8ec-ac3d300dbf91 61 fields · synced Jul 16, 2026
- EUDAMED e6870805-bc58-4ea2-8c8b-6b67341c8a04 61 fields · synced Jul 19, 2026
- EUDAMED bb3deaf4-7651-4073-991c-e9c8a489faff 61 fields · synced Jul 21, 2026
- EUDAMED 39b15f46-4644-4033-9ba6-f8791bdfd538 61 fields · synced Jul 23, 2026
- EUDAMED dd3880ca-83cd-4816-a212-b6714c4e21fd 61 fields · synced Jul 26, 2026
- EUDAMED 116cfef9-1f77-4670-815e-1b41d2be3d31 61 fields · synced Jul 27, 2026
- EUDAMED 9b028c8f-0cc4-4270-9b0a-56f727587f0c 61 fields · synced Aug 4, 2026