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Scan Body
EUDAMEDClass I (EU MDR)
Ref 7680123Model Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8
Identity
- Trade Name
- Scan Body EUDAMED
- Device Name
- Scan Body EUDAMED
- Model / Reference
- Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8 EUDAMED7680123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877826727 EUDAMED
- Basic UDI-DI
- 697259778EM011MK 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 | 697259778EM011MK | 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 cc5afc82-8a56-4c66-803f-53cd0c3f41e0 61 fields · synced Jun 18, 2026