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Scanbody
EUDAMEDClass I (EU MDR)
Ref DMC-SModel DMC-L、DMC-M、DMC-SRef DMC-MRef DMC-LRef DMC-LH1
Identity
- Device Name
- Scanbody EUDAMED
- Model / Reference
- DMC-L、DMC-M、DMC-S EUDAMEDDMC-S EUDAMEDDMC-M EUDAMEDDMC-L EUDAMEDDMC-LH1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971246542071 EUDAMED06971246542064 EUDAMED06971246542057 EUDAMED06971246542088 EUDAMED
- Basic UDI-DI
- 697124654ScanbodyTK EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly 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
Scanbody 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 | 697124654ScanbodyTK | Class I | Active |
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Manufacturer
- Manufacturer
- BLZ Technology (Wuhan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019762
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED 9fd4c0ef-cf71-4b8b-8d6c-9dd65cd3a818 61 fields · synced Sep 17, 2026
- EUDAMED f280b3cc-4f0d-451d-afee-e96620a309de 61 fields · synced May 18, 2026
- EUDAMED 8259e172-2e7a-4cc4-87fa-8df674ee15b0 61 fields · synced May 19, 2026
- EUDAMED 02653081-844e-4847-ab05-d90ed328b446 61 fields · synced Sep 17, 2026