Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- Q0199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971246542040 EUDAMED
- Basic UDI-DI
- 697124654IntraoralScan92 EUDAMED
- Direct Marketing DI
- 06971246542040 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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 111f370e-9cdb-4442-852f-254de5ddc8f1 61 fields · synced Jun 19, 2026