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Dental Loupes
EUDAMEDClass I (EU MDR)
Ref Eyezoom 4XModel Eyezoom 2X, Eyezoom 2.5X,Eyezoom 3X,Eyezoom 3.5X, Eyezoom 4X ,Eyezoom 4.5X
Identity
- Device Name
- Dental Loupes EUDAMED
- Model / Reference
- Eyezoom 2X, Eyezoom 2.5X,Eyezoom 3X,Eyezoom 3.5X, Eyezoom 4X ,Eyezoom 4.5X EUDAMEDEyezoom 4X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978203142633 EUDAMED
- Basic UDI-DI
- 697820314DENTALLOUPESDJ EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Dental Loupes by Shenzhen Americuras 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 | 697820314DENTALLOUPESDJ | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Americuras Co., Ltd
- EUDAMED SRN
- CN-MF-000048352
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8bf422d6-0790-41cb-bc4e-64173137e9fe 61 fields · synced Jun 18, 2026