Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- MaxOral V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063094485 EUDAMED
- Basic UDI-DI
- 697506309ISMSZ EUDAMED
- Direct Marketing DI
- 06975063094485 EUDAMED
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Shanghai Maxflex 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 | 697506309ISMSZ | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Maxflex Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032435
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED fe456fe2-0156-486e-9645-84f8e7a927c1 61 fields · synced Jul 18, 2026