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Intraoral Scanner
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7680071Model Helios 680, MyScanner Pro, Helios 6X ProRef 7680038Model Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRORef 7680078Model Helios 700, Helios 780, MyScanner-W, Helios 7X ProRef 7680037Ref 7680129Ref 7680036Ref 7680051Ref 7680082Ref 7680009Ref 7680065Ref 7680158
Identity
- Trade Name
- Intraoral Scanner EUDAMEDEighteeth FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- Helios 680, MyScanner Pro, Helios 6X Pro EUDAMED7680071 EUDAMEDHelios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO EUDAMED7680038 EUDAMEDHelios 700, Helios 780, MyScanner-W, Helios 7X Pro EUDAMED7680078 EUDAMED7680037 EUDAMED7680129 EUDAMED7680036 EUDAMED7680051 EUDAMED7680082 EUDAMED7680009 EUDAMED7680065 EUDAMED7680158 EUDAMEDHelios 500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941877821852 EUDAMED06941877812508 EUDAMED06941877822736 EUDAMED06941877812492 EUDAMED06941877827014 EUDAMED06941877812485 EUDAMED06941877813321 EUDAMED06941877825058 EUDAMED06941877807962 EUDAMEDFDA UDI06941877821180 EUDAMED06941877827984 EUDAMED
- Basic UDI-DI
- 697259778EM006MS EUDAMED697259778EM002MJ EUDAMED697259778EM008MW EUDAMED
- Direct Marketing DI
- 06941877821852 EUDAMED06941877812508 EUDAMED06941877822736 EUDAMED06941877812492 EUDAMED06941877827014 EUDAMED06941877812485 EUDAMED06941877813321 EUDAMED06941877825058 EUDAMED06941877807962 EUDAMED06941877821180 EUDAMED06941877827984 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
- Italy EUDAMEDCzechia EUDAMEDPoland EUDAMEDGreece 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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Intraoral Scanner by Changzhou Sifary Medical Technology 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
- 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 (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 | 697259778EM006MS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (12)
- EUDAMED d2d62fbe-314f-462b-a151-30c65dd8cf0c 61 fields · synced Jul 29, 2026
- EUDAMED 0e7ceab2-e970-4b75-be1d-cbf0d794454c 61 fields · synced May 17, 2026
- EUDAMED 10360160-c708-416e-bb94-ff833f3015de 61 fields · synced May 17, 2026
- EUDAMED c1aee2ff-ddc6-4c86-8641-403198a620d3 61 fields · synced May 17, 2026
- EUDAMED a48df57a-57af-4ee8-905c-119151e8cf70 61 fields · synced May 17, 2026
- EUDAMED 9514fb89-0311-4af7-b5f7-7fd49b016b42 61 fields · synced May 17, 2026
- EUDAMED 2a448766-0bd0-4310-a06b-34885056e88e 61 fields · synced May 18, 2026
- EUDAMED 687f3718-62eb-4cbc-a1fe-0833eabdfbdc 61 fields · synced May 18, 2026
- EUDAMED 8adfa470-d4cb-45b6-b769-210561eb6034 61 fields · synced May 18, 2026
- EUDAMED 9e7a0135-0212-4202-a32c-02abd88bd187 61 fields · synced May 18, 2026
- EUDAMED 2d4bc23d-5001-4ffe-bdac-a22e234df417 61 fields · synced May 18, 2026
- FDA UDI adf8dac8-db5a-48ce-b09c-7a857a367f46 32 fields · synced May 30, 2026