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Reusable Tip of Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref 7680043Model Helios 680 Size S, Helios 680 Size L, INNO SCAN Size S, INNO SCAN Size L
Identity
- Trade Name
- Reusable Tip of Intraoral Scanner EUDAMED
- Device Name
- Reusable Tip of Intraoral Scanner EUDAMED
- Model / Reference
- Helios 680 Size S, Helios 680 Size L, INNO SCAN Size S, INNO SCAN Size L EUDAMED7680043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877812621 EUDAMED
- Basic UDI-DI
- 697259778EM007MU EUDAMED
- Direct Marketing DI
- 06941877812621 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 | 697259778EM007MU | 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 (1)
- EUDAMED 90eedbe3-0cfe-46b1-803e-113b169af0f9 61 fields · synced Jun 19, 2026