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Reusable Tip of Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref 7680020Model Helios 500 Size S, Helios 500 Size L
Identity
- Trade Name
- Reusable Tip of Intraoral Scanner EUDAMED
- Device Name
- Reusable Tip of Intraoral Scanner EUDAMED
- Model / Reference
- Helios 500 Size S, Helios 500 Size L EUDAMED7680020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975132953675 EUDAMED
- Basic UDI-DI
- 697259778EM004MN EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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 | 697259778EM004MN | 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 dff6d78c-9762-4da2-8cd2-b8971c9d6fee 61 fields · synced Jun 19, 2026