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Scan Body
EUDAMEDClass I (EU MDR)
Ref 7680099Model Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8
Identity
- Trade Name
- Scan Body EUDAMED
- Device Name
- Scan Body EUDAMED
- Model / Reference
- Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8 EUDAMED7680099 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877826680 EUDAMED
- Basic UDI-DI
- 697259778EM010MH EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Scan Body 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 | 697259778EM010MH | 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 128c9ced-f027-47bc-ae8d-2206e8977f72 61 fields · synced Jun 19, 2026