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Desktop Holder
EUDAMEDClass I (EU MDR)
Ref 6583246Model AS 100, AS 200E, AS 260, AS 260a, S300W, ST 200E, ST 300E, NeoScan 1000, NeoScan 2000, Owandy ios, Owandy ios Wireless, DI-1Ref 6583396
Identity
- Trade Name
- Desktop Holder EUDAMED
- 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 EUDAMED6583246 EUDAMED6583396 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973993441546 EUDAMED06973993441744 EUDAMED
- Basic UDI-DI
- 697399344alliedstar01SL EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental implant suprastructure, temporary, preformed, single-use
Desktop Holder by Alliedstar Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697399344alliedstar01SL | Class I | Active |
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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 42f68b42-d1fa-4346-b097-091c3bc14f7d 61 fields · synced Jul 30, 2026
- EUDAMED 8f4462b4-ae28-4025-84be-2a1af720911b 61 fields · synced Jul 27, 2026
- EUDAMED faec6bdf-3ea3-4814-8be7-508361765de6 61 fields · synced Jul 30, 2026