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Reusable Tip of Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref 7680023Model Helios 600 Size L, Helios 600 Size SRef 7680149Model Helios 680 Size S, Helios 680 Size L, INNO SCAN Size S, INNO SCAN Size LRef 7680021Model Helios 500 Size S, Helios 500 Size LRef 7680150Ref 7680042Ref 7680086Model Helios 700 Size S, Helios 700 Size L, SCAN-MI PRO Size S, SCAN-MI PRO Size LRef 7680022Ref 7680085Ref 7680152Ref 7680035Model Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRORef 7680153Ref 7680013
Identity
- Trade Name
- Reusable Tip of Intraoral Scanner EUDAMEDIntraoral Scanner EUDAMED
- Device Name
- Reusable Tip of Intraoral Scanner EUDAMEDIntraoral Scanner EUDAMED
- Model / Reference
- Helios 600 Size L, Helios 600 Size S EUDAMED7680023 EUDAMEDHelios 680 Size S, Helios 680 Size L, INNO SCAN Size S, INNO SCAN Size L EUDAMED7680149 EUDAMEDHelios 500 Size S, Helios 500 Size L EUDAMED7680021 EUDAMED7680150 EUDAMED7680042 EUDAMEDHelios 700 Size S, Helios 700 Size L, SCAN-MI PRO Size S, SCAN-MI PRO Size L EUDAMED7680086 EUDAMED7680022 EUDAMED7680085 EUDAMED7680152 EUDAMEDHelios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO EUDAMED7680035 EUDAMED7680153 EUDAMED7680013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975132957147 EUDAMED06941877827663 EUDAMED06975132957536 EUDAMED06941877827670 EUDAMED06941877812614 EUDAMED06941877825478 EUDAMED06975132957703 EUDAMED06941877825461 EUDAMED06941877827786 EUDAMED06941877812478 EUDAMED06941877827793 EUDAMED06941877809966 EUDAMED
- Basic UDI-DI
- 697259778EM003ML EUDAMED697259778EM007MU EUDAMED697259778EM004MN EUDAMED697259778EM009MY EUDAMED697259778EM002MJ EUDAMED
- Direct Marketing DI
- 06975132957147 EUDAMED06941877827663 EUDAMED06941877827670 EUDAMED06941877812614 EUDAMED06941877825478 EUDAMED06975132957703 EUDAMED06941877825461 EUDAMED06941877827786 EUDAMED06941877812478 EUDAMED06941877827793 EUDAMED06941877809966 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMEDQ010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMEDItaly EUDAMEDBulgaria EUDAMEDGreece 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
Reusable Tip of Intraoral Scanner by Changzhou Sifary Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697259778EM003ML | Class I | Active |
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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 b1ca8faf-47ab-4a53-ba9f-a9a0d6856446 61 fields · synced Jul 30, 2026
- EUDAMED fe74a079-9050-4df3-a8b5-1fa0ba0fda6d 61 fields · synced May 16, 2026
- EUDAMED eb8b6658-e465-4743-ab5b-185d1d17e0ac 61 fields · synced May 16, 2026
- EUDAMED 2acf65aa-e590-43ff-95fe-401be5e206ca 61 fields · synced May 17, 2026
- EUDAMED f70e4434-5ccf-4e86-825e-c7bae0118af2 61 fields · synced May 17, 2026
- EUDAMED 5a062ced-c80d-4b1c-978a-b41536bca7a0 61 fields · synced May 17, 2026
- EUDAMED 676e3c0e-5d17-4f0b-9a5a-9bd5a0b8458c 61 fields · synced May 17, 2026
- EUDAMED 6160e234-7d0c-4c57-8809-d79219f3b872 61 fields · synced May 17, 2026
- EUDAMED 2da36f49-dd3c-45f8-8b5b-aa3294343f6b 61 fields · synced May 17, 2026
- EUDAMED 2e3a1813-f7d0-4a3c-9456-248cb8f3f877 61 fields · synced May 18, 2026
- EUDAMED e0a67769-f2fd-4717-891f-681bf8901827 61 fields · synced May 18, 2026
- EUDAMED 1963b535-e6c8-4d6f-91cf-0396179e3362 61 fields · synced May 19, 2026