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Orion Kit
EUDAMEDClass I (EU MDR)
Ref 7680091Model Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8
Identity
- Trade Name
- Orion Kit EUDAMED
- Device Name
- Scan Body Kit EUDAMED
- Model / Reference
- Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8 EUDAMED7680091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877826604 EUDAMED
- Basic UDI-DI
- 697259778EM016MV EUDAMED
- Direct Marketing DI
- 06941877826604 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
Orion Kit 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 | 697259778EM016MV | 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 71b8c9ef-a4ef-4d8a-8e14-a980bac30a3e 61 fields · synced Jun 18, 2026