Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- NT 510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971246542033 EUDAMED
- Basic UDI-DI
- 697124654IntraoralScan92 EUDAMED
- Direct Marketing DI
- 06971246542033 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Intraoral Scanner by BLZ Technology (Wuhan) 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 | 697124654IntraoralScan92 | Class I | Active |
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Manufacturer
- Manufacturer
- BLZ Technology (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019762
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED f13bf9f6-6027-4f7e-992f-eee7a6228e4b 61 fields · synced Jun 20, 2026